<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698320</url>
  </required_header>
  <id_info>
    <org_study_id>ABS-AS-307</org_study_id>
    <nct_id>NCT01698320</nct_id>
  </id_info>
  <brief_title>Safety Study of Albuterol Spiromax® in Subjects With Asthma</brief_title>
  <official_title>A Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax® in Subjects With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teva Branded Pharmaceutical Products R&amp;D, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teva Branded Pharmaceutical Products R&amp;D, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks&#xD;
      during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period&#xD;
      followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax®&#xD;
      device performance through the life of the device during the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)</measure>
    <time_frame>Day 1 to Week 12</time_frame>
    <description>Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)</measure>
    <time_frame>Weeks 13-52</time_frame>
    <description>Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrocardiogram (ECG) Results At Weeks 0, 12, and 52</measure>
    <time_frame>Weeks 0 (screening visit), 12, and 52</time_frame>
    <description>A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52</measure>
    <time_frame>Week 0, Week 12 and Week 52</time_frame>
    <description>Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.&#xD;
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Pulse Measurements to Week 12 and Week 52</measure>
    <time_frame>Week 0, Week 12 and Week 52</time_frame>
    <description>Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.&#xD;
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52</measure>
    <time_frame>Weeks 0, 12 and 52</time_frame>
    <description>The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.&#xD;
HEENT = head, eyes, ears, nose, throat</description>
  </primary_outcome>
  <other_outcome>
    <measure>Composite Measurement of Device Ruggedness From Baseline to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).</description>
  </other_outcome>
  <other_outcome>
    <measure>Device Invitro Evaluations to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:&#xD;
Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing&#xD;
Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing</description>
  </other_outcome>
  <other_outcome>
    <measure>Daily AM Peak Expiratory Flow (PEF) to Week 52</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Placebo MDPI-Albuterol MDPI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Albuterol MDPI-Albuterol MDPI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo MDPI</intervention_name>
    <description>Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.</description>
    <arm_group_label>Placebo MDPI-Albuterol MDPI</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albuterol MDPI</intervention_name>
    <description>Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.</description>
    <arm_group_label>Albuterol MDPI-Albuterol MDPI</arm_group_label>
    <arm_group_label>Placebo MDPI-Albuterol MDPI</arm_group_label>
    <other_name>ProAir® RespiClick</other_name>
    <other_name>Albuterol Spiromax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent and HIPAA signed and dated by the subject or written informed&#xD;
             assent signed and dated both by the subject and/or parent/caregiver/legal guardian&#xD;
             before conducting any study related procedure.&#xD;
&#xD;
          -  Males or females with asthma ages 12 years or older at screening.&#xD;
&#xD;
          -  Documented history of persistent asthma and current use of an MDI containing any&#xD;
             short-acting beta-adrenergic agonist (e.g. albuterol, levalbuterol,) on average of at&#xD;
             least once/week over the 4-weeks prior to screening. The asthma diagnosis must be&#xD;
             consistent with the diagnosis of asthma as per the National Asthma Education and&#xD;
             Prevention Program.&#xD;
&#xD;
          -  If female, is currently not pregnant, breast feeding, or attempting to become pregnant&#xD;
             (for 4 weeks before the screening visit and throughout the duration of the study), and&#xD;
             is of Non-childbearing potential, defined as:&#xD;
&#xD;
               -  ≥1 year post-menopausal or&#xD;
&#xD;
               -  Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or&#xD;
                  hysterectomy) or is of&#xD;
&#xD;
               -  Childbearing potential, has a negative serum pregnancy test, and is willing to&#xD;
                  commit to using a consistent and acceptable method of birth control&#xD;
&#xD;
          -  General good health in the opinion of the investigator as indicated by medical&#xD;
             history, physical examination, laboratory tests (hematology, serum chemistry and&#xD;
             urinalysis) assessed as either normal or abnormal not clinically significant (NCS) per&#xD;
             the principal investigator, as well as a 12-lead ECG interpreted as either &quot;Normal&quot; or&#xD;
             &quot;Abnormal NCS&quot; as determined by the central cardiologist. Subjects must also be free&#xD;
             of any clinically significant, uncontrolled concomitant conditions other than asthma&#xD;
             that could interfere with study conduct, influence the interpretation of study&#xD;
             observations/results, or put the subject at increased risk during the trial.&#xD;
&#xD;
          -  Capable of understanding the requirements, risks, and benefits of study participation,&#xD;
             and, as judged by the investigator, and being compliant with all study requirements&#xD;
             (visits, record-keeping, etc).&#xD;
&#xD;
          -  Non-smoker for at least one year prior to the screening visit and a maximum pack-year&#xD;
             (PY) smoking history of 10 years.&#xD;
&#xD;
          -  Able to demonstrate proper inhaler technique with study inhaler.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for&#xD;
             in vitro fertilization during the study period or for 30 days following the subject's&#xD;
             last study related visit.&#xD;
&#xD;
          -  Participation in any investigational drug trial within 30 days preceding the screening&#xD;
             visit or planned participation in another investigational drug trial at any time&#xD;
             during this trial.&#xD;
&#xD;
          -  A known hypersensitivity to albuterol or any of the excipients in the formulations.&#xD;
&#xD;
          -  History of severe milk protein allergy&#xD;
&#xD;
          -  History of an upper or lower respiratory tract infection or disorder (including, but&#xD;
             not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media,&#xD;
             influenza, etc) which is not resolved at least 1 week prior to the SV.&#xD;
&#xD;
          -  History of alcohol or drug abuse within two years preceding the SV.&#xD;
&#xD;
          -  Use of any protocol prohibited concomitant medications for asthma (any oral&#xD;
             β2-adrenergic agonists) or any protocol prohibited concomitant non-asthma medications&#xD;
             including treatment with β2-adrenergic receptor antagonists and non-selective&#xD;
             β-receptor blocking agents such as β-blocking anti-hypertensive products (administered&#xD;
             by any route), MAO inhibitors, and/or tricyclic antidepressants. (Subject's own MDI&#xD;
             short-acting β-agonist rescue inhaler should be used until the start of the Run-In&#xD;
             period when a study rescue inhaler is provided.)&#xD;
&#xD;
          -  Inability or unwillingness to comply with the protocol requirements.&#xD;
&#xD;
          -  History of life-threatening asthma [defined here as an asthma episode requiring&#xD;
             intubation and/or associated with hypercapnea, respiratory arrest or hypoxic&#xD;
             seizures.]&#xD;
&#xD;
          -  Any asthma exacerbation within 3 months of the SV requiring oral or systemic&#xD;
             corticosteroids or any hospitalization for asthma within 6 months of the SV.&#xD;
&#xD;
        Note: An exacerbation of asthma is defined as any worsening of asthma requiring any&#xD;
        treatment other than rescue albuterol or the subject's regular asthma maintenance therapy.&#xD;
        This includes requiring the use of systemic corticosteroids and/or emergency room visit or&#xD;
        hospitalization or a change in subject's regular asthma maintenance treatment. A subject&#xD;
        does not need to be withdrawn from the study due to an asthma exacerbation unless&#xD;
        hospitalization is required or unless the principal investigator believes it is in the&#xD;
        subjects' best interest to withdraw from the study.&#xD;
&#xD;
          -  Previous participation in an inhaled Albuterol Spiromax® (Teva) study, with the&#xD;
             exception of the ABS-AS-306 study.&#xD;
&#xD;
          -  Study participation by clinical investigator site employees and/or their immediate&#xD;
             relatives.&#xD;
&#xD;
          -  Study participation by related or non-related individuals living in the same&#xD;
             household, i.e. only one subject per household may participate in the study.&#xD;
&#xD;
          -  Any clinically significant endocrine, hematological, hepatic, renal, gastrointestinal,&#xD;
             neurological, cardiac, metabolic, immunological, any non-asthmatic acute or chronic&#xD;
             pulmonary condition (including but not limited to bronchitis, emphysema, active&#xD;
             tuberculosis, bronchiectasis, cystic fibrosis), and malignancy other than basal cell&#xD;
             carcinoma. Significant is defined for this protocol as any condition that, in the&#xD;
             opinion of the investigator, would put the safety of the subject at risk through&#xD;
             participation, or which could affect the safety analyses.&#xD;
&#xD;
          -  Any medical or psychological condition that in the investigator's opinion should&#xD;
             preclude enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Teva Investigational Site 10169</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10157</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10148</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10159</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10158</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10168</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10154</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10161</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10162</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10166</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10151</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10142</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10152</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10146</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10160</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10144</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10141</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10153</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10147</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10143</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10167</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10150</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10156</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10155</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10149</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10145</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10170</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10163</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10165</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10164</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>July 13, 2015</results_first_submitted>
  <results_first_submitted_qc>August 12, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 19, 2015</results_first_posted>
  <disposition_first_submitted>May 8, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>May 8, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 26, 2014</disposition_first_posted>
  <last_update_submitted>August 12, 2015</last_update_submitted>
  <last_update_submitted_qc>August 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 33 patients who were screened but not enrolled, 28 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 3 patients were lost to follow-up before the baseline visit.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Enrolled Subjects</title>
          <description>Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.</description>
        </group>
        <group group_id="P2">
          <title>Placebo MDPI-Albuterol MDPI</title>
          <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
        </group>
        <group group_id="P3">
          <title>Albuterol MDPI-Albuterol MDPI</title>
          <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Run-In Period (Week -1 to Day 0)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="364"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="337"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Inclusion/exclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12-Week Double-Blind Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="169"/>
                <participants group_id="P3" count="168"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="170">One participant took both placebo and albuterol so is counted in both treatment groups for safety.</participants>
                <participants group_id="P3" count="168"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="165"/>
                <participants group_id="P3" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor requested subject withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>40-Week Open-Label Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="165"/>
                <participants group_id="P3" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="146"/>
                <participants group_id="P3" count="146"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor requested subject withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set of randomized subjects</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo MDPI-Albuterol MDPI</title>
          <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
        </group>
        <group group_id="B2">
          <title>Albuterol MDPI-Albuterol MDPI</title>
          <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="169"/>
            <count group_id="B2" value="168"/>
            <count group_id="B3" value="337"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.1" spread="15.14"/>
                    <measurement group_id="B2" value="36.6" spread="15.04"/>
                    <measurement group_id="B3" value="36.8" spread="15.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>12-17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65+ years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.3" spread="21.09"/>
                    <measurement group_id="B2" value="81.2" spread="21.4"/>
                    <measurement group_id="B3" value="81.8" spread="21.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.4" spread="8.67"/>
                    <measurement group_id="B2" value="168.6" spread="9.52"/>
                    <measurement group_id="B3" value="168.0" spread="9.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="6.96"/>
                    <measurement group_id="B2" value="28.5" spread="6.81"/>
                    <measurement group_id="B3" value="28.8" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)</title>
        <description>Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.</description>
        <time_frame>Day 1 to Week 12</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
          <group group_id="O2">
            <title>Albuterol MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)</title>
          <description>Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.</description>
          <population>Safety population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withdrawn from treatment due to adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Composite Measurement of Device Ruggedness From Baseline to Week 52</title>
        <description>Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).</description>
        <time_frame>Baseline to Week 52</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Device Invitro Evaluations to Week 52</title>
        <description>Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:&#xD;
Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing&#xD;
Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing</description>
        <time_frame>Baseline to Week 52</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Daily AM Peak Expiratory Flow (PEF) to Week 52</title>
        <description>Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.</description>
        <time_frame>Baseline to Week 52</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)</title>
        <description>Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.</description>
        <time_frame>Weeks 13-52</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
          <group group_id="O2">
            <title>Albuterol MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)</title>
          <description>Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.</description>
          <population>Safety population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withdrawn from treatment due to adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Electrocardiogram (ECG) Results At Weeks 0, 12, and 52</title>
        <description>A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.</description>
        <time_frame>Weeks 0 (screening visit), 12, and 52</time_frame>
        <population>Safety population. Participants with assessments at each time point are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
          <group group_id="O2">
            <title>Albuterol MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Electrocardiogram (ECG) Results At Weeks 0, 12, and 52</title>
          <description>A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.</description>
          <population>Safety population. Participants with assessments at each time point are reported.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0: Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0: Abnormal, not clinically relevant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0: Abnormal, clinically relevant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Normal (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Abnormal, not clinically relevant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Abnormal, clinically relevant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Normal (n=152, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Abnormal, not clinically relevant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52: Abnormal, clinically relevant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52</title>
        <description>Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.&#xD;
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.</description>
        <time_frame>Week 0, Week 12 and Week 52</time_frame>
        <population>Safety population. Participants with assessments at each time point are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
          <group group_id="O2">
            <title>Albuterol MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52</title>
          <description>Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.&#xD;
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.</description>
          <population>Safety population. Participants with assessments at each time point are reported.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic BP Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="11.27"/>
                    <measurement group_id="O2" value="0.2" spread="10.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic BP Week 52 (n=159, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="11.54"/>
                    <measurement group_id="O2" value="0.7" spread="10.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="9.16"/>
                    <measurement group_id="O2" value="0.3" spread="7.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP Week 52 (n=159, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="9.14"/>
                    <measurement group_id="O2" value="1.0" spread="8.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Pulse Measurements to Week 12 and Week 52</title>
        <description>Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.&#xD;
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.</description>
        <time_frame>Week 0, Week 12 and Week 52</time_frame>
        <population>Safety population. Participants with assessments at each time point are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
          <group group_id="O2">
            <title>Albuterol MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Measurements to Week 12 and Week 52</title>
          <description>Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.&#xD;
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.</description>
          <population>Safety population. Participants with assessments at each time point are reported.</population>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pulse Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="9.40"/>
                    <measurement group_id="O2" value="0.9" spread="9.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse Week 52 (n=159, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="10.08"/>
                    <measurement group_id="O2" value="-0.3" spread="9.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52</title>
        <description>The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.&#xD;
HEENT = head, eyes, ears, nose, throat</description>
        <time_frame>Weeks 0, 12 and 52</time_frame>
        <population>Safety population. Participants with assessments at each time point are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
          <group group_id="O2">
            <title>Albuterol MDPI-Albuterol MDPI</title>
            <description>During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.&#xD;
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52</title>
          <description>The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.&#xD;
HEENT = head, eyes, ears, nose, throat</description>
          <population>Safety population. Participants with assessments at each time point are reported.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="168"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>General appearance - Week 0 (n=170, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General appearance - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General appearance - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEENT - Week 0 (n=170, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEENT - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEENT - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest and lungs - Week 0 (n=170, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest and lungs - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest and lungs - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart - Week 0 (n=170, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen - Week 0 (n=168, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal - Week 0 (n=169, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin - Week 0 (n=169, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin - Week 12 (n=167, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes - Week 0 (n=169, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes - Week 120 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological - Week 0 (n=169, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological - Week 52 (n=162, 161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremities/back - Week 0 (n=169, 167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremities/back - Week 12 (n=166, 155)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremities/back - Week 52 (n=162, 160)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 to Week 52</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Albuterol MDPI - Double-blind Period</title>
          <description>Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.</description>
        </group>
        <group group_id="E2">
          <title>Placebo MDPI - Double-blind Period</title>
          <description>Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.</description>
        </group>
        <group group_id="E3">
          <title>Albuterol MDPI (Formerly Placebo) - Open Label Period</title>
          <description>After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).</description>
        </group>
        <group group_id="E4">
          <title>Albuterol MDPI (Formerly Albuterol) - Open Label Period</title>
          <description>After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="169"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="169"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="168"/>
                <counts group_id="E2" subjects_affected="80" subjects_at_risk="170"/>
                <counts group_id="E3" subjects_affected="64" subjects_at_risk="169"/>
                <counts group_id="E4" subjects_affected="67" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="168"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="170"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="169"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="168"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="170"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="169"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="168"/>
                <counts group_id="E2" events="22" subjects_affected="17" subjects_at_risk="170"/>
                <counts group_id="E3" events="20" subjects_affected="16" subjects_at_risk="169"/>
                <counts group_id="E4" events="26" subjects_affected="20" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="168"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="170"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="169"/>
                <counts group_id="E4" events="23" subjects_affected="19" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="26" subjects_affected="23" subjects_at_risk="168"/>
                <counts group_id="E2" events="36" subjects_affected="31" subjects_at_risk="170"/>
                <counts group_id="E3" events="36" subjects_affected="27" subjects_at_risk="169"/>
                <counts group_id="E4" events="16" subjects_affected="15" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="19" subjects_affected="10" subjects_at_risk="168"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="170"/>
                <counts group_id="E3" events="25" subjects_affected="8" subjects_at_risk="169"/>
                <counts group_id="E4" events="18" subjects_affected="10" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="168"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="170"/>
                <counts group_id="E3" events="19" subjects_affected="18" subjects_at_risk="169"/>
                <counts group_id="E4" events="14" subjects_affected="11" subjects_at_risk="168"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="168"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="170"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="169"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="168"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical Research</name_or_title>
      <organization>Teva Branded Pharmaceutical Products, R&amp;D Inc.</organization>
      <phone>1-215-591-3000</phone>
      <email>ustevatrials@tevapharm.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698320
org study id: ABS-AS-307
nct id: NCT01698320
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks
      during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period
      followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax®
      device performance through the life of the device during the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
time frame: Day 1 to Week 12
description: Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
measure: Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
time frame: Weeks 13-52
description: Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
measure: Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
time frame: Weeks 0 (screening visit), 12, and 52
description: A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.
measure: Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
time frame: Week 0, Week 12 and Week 52
description: Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.
measure: Change From Baseline in Pulse Measurements to Week 12 and Week 52
time frame: Week 0, Week 12 and Week 52
description: Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.
Week 12 values represent change from Week 0. Week 52 values represent change from Week 12.
measure: Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
time frame: Weeks 0, 12 and 52
description: The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.
HEENT = head, eyes, ears, nose, throat
measure: Composite Measurement of Device Ruggedness From Baseline to Week 52
time frame: Baseline to Week 52
description: Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).
measure: Device Invitro Evaluations to Week 52
time frame: Baseline to Week 52
description: Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:
Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing
Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing
measure: Daily AM Peak Expiratory Flow (PEF) to Week 52
time frame: Baseline to Week 52
description: Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.
arm group label: Placebo MDPI-Albuterol MDPI
arm group type: Placebo Comparator
description: During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
arm group label: Albuterol MDPI-Albuterol MDPI
arm group type: Experimental
description: During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.
The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
intervention type: Drug
intervention name: Placebo MDPI
description: Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.
arm group label: Placebo MDPI-Albuterol MDPI
other name: placebo
intervention type: Drug
intervention name: Albuterol MDPI
description: Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.
arm group label: Albuterol MDPI-Albuterol MDPI
arm group label: Placebo MDPI-Albuterol MDPI
other name: ProAir® RespiClick
other name: Albuterol Spiromax
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Albuterol
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