<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/NCT02238106</url>
  </required_header>
  <id_info>
    <org_study_id>1184.12</org_study_id>
    <nct_id>NCT02238106</nct_id>
  </id_info>
  <brief_title>Salmeterol Inhalation Powder Administered as the Xinafoate Salt From Hard Polyethylene Capsules Via the HandiHaler® 2, and Serevent® Diskus® in Patients With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder (12.5 μg, 25 μg and 50 Salmeterol), Administered as the Xinafoate Salt From Hard Polyethylene Capsules Via the HandiHaler® 2, and Serevent® Diskus® (50 μg Salmeterol) in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The primary objective of this trial was to establish non-inferiority of lung function&#xD;
      response to two doses [25 μg (1 capsule) and 50 μg (2 capsules of 25 μg)] salmeterol,&#xD;
      administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene&#xD;
      (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg,&#xD;
      administered as the xinafoate salt) following single dose inhalation in patients with COPD. A&#xD;
      hard capsule with half the strength (12.5 μg) was included to investigate a dose ordering&#xD;
      effect.&#xD;
&#xD;
      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation&#xD;
      powder delivered by HandiHaler® 2 from the PE hard capsule(s) and salmeterol xinafoate&#xD;
      delivered by Serevent® Diskus®, and to compare the safety of the different pharmaceutical&#xD;
      forms and/or doses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2005</start_date>
  <primary_completion_date type="Actual">February 2006</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in peak FEV1</measure>
    <time_frame>within 3 hours post-dosing</time_frame>
    <description>Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak forced vital capacity (FVC)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FVC AUC0-12h</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual FEV1 measurements at each time point</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual FVC measurements at each time point</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (terminal half-life of the analyte in plasma)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTih (mean residence time of the analyte in the body after inhalational administration)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)</measure>
    <time_frame>0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)</measure>
    <time_frame>0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)</measure>
    <time_frame>0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 36 days</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Salmeterol inhalation powder, medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered via HandiHaler®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol inhalation powder, low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>administered via HandiHaler®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmeterol inhalation powder, high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>administered via HandiHaler®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serevent® Diskus®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>administered via Diskus®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>administered via Diskus® or HandiHaler®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salmeterol medium dose</intervention_name>
    <arm_group_label>Salmeterol inhalation powder, medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salmeterol low dose</intervention_name>
    <arm_group_label>Salmeterol inhalation powder, low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salmeterol high dose</intervention_name>
    <arm_group_label>Salmeterol inhalation powder, high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Serevent® Diskus®</intervention_name>
    <arm_group_label>Serevent® Diskus®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo HandiHaler®</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Salmeterol inhalation powder, low dose</arm_group_label>
    <arm_group_label>Salmeterol inhalation powder, medium dose</arm_group_label>
    <arm_group_label>Serevent® Diskus®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Diskus®</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Salmeterol inhalation powder, high dose</arm_group_label>
    <arm_group_label>Salmeterol inhalation powder, low dose</arm_group_label>
    <arm_group_label>Salmeterol inhalation powder, medium dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients must sign an informed consent consistent with International Conference on&#xD;
             Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior&#xD;
             to any study-related procedures, which includes medication washout and restrictions&#xD;
&#xD;
          2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must&#xD;
             meet the following spirometric criteria:&#xD;
&#xD;
               -  Patients must have relatively stable* airway obstruction with a pre-dose FEV1 ≤&#xD;
                  60% of predicted normal and FEV1 ≤ 70% of FVC at Visits 1 and 2&#xD;
&#xD;
                    -  *The enrolment of patients who have had an exacerbation within six weeks&#xD;
                       prior to planned study entry should be postponed&#xD;
&#xD;
          3. At Visit 1, patients must demonstrate an improvement in FEV1 of ≥12% over the&#xD;
             pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 µg salbutamol&#xD;
             (Sultanol® MDI)&#xD;
&#xD;
          4. Male or female patients 40 years of age or older&#xD;
&#xD;
          5. Patients must be current or ex-smokers with a smoking history of more than 10&#xD;
             pack-years&#xD;
&#xD;
          6. Patients must be able to perform technically acceptable pulmonary function tests&#xD;
             during the study period as required in the protocol&#xD;
&#xD;
          7. Patients must be able to inhale medication in a competent manner from the HandiHaler®&#xD;
             2 device and the Diskus® device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with significant diseases other than COPD will be excluded. A significant&#xD;
             disease is defined as a disease which in the opinion of the investigator may either&#xD;
             put the patient at risk because of participation in the study or a disease which may&#xD;
             influence the results of the study or the patient's ability to participate in the&#xD;
             study.&#xD;
&#xD;
          2. Patients with a recent history (i.e., six months or less) of myocardial infarction&#xD;
&#xD;
          3. Patients who have been hospitalized for heart failure (New York Heart Association&#xD;
             (NYHA) class III or IV) within the past year&#xD;
&#xD;
          4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac&#xD;
             arrhythmia requiring intervention or a change in drug therapy within the past year&#xD;
&#xD;
          5. Patients with malignancy for which the patient has undergone resection, radiation&#xD;
             therapy or chemotherapy within the last five years. Patients with treated basal cell&#xD;
             carcinoma are allowed&#xD;
&#xD;
          6. Patients with a history of asthma, allergic rhinitis or atopy or who have a total&#xD;
             blood eosinophil count ≥600/mm3&#xD;
&#xD;
          7. Patients with a history of life threatening pulmonary obstruction, or a history of&#xD;
             cystic fibrosis or clinically evident bronchiectasis&#xD;
&#xD;
          8. Patients with known active tuberculosis&#xD;
&#xD;
          9. Patients with significant alcohol or drug abuse within the past two years&#xD;
&#xD;
         10. Patients who have undergone thoracotomy with pulmonary resection. Patients with a&#xD;
             history of thoracotomy for other reasons should be evaluated as per exclusion&#xD;
             criterion No. 1.&#xD;
&#xD;
         11. Patients who have completed a pulmonary rehabilitation program in the six weeks prior&#xD;
             to the Screening Visit (Visit 1) or patients who are currently in a pulmonary&#xD;
             rehabilitation program that will not be maintained throughout the duration of the&#xD;
             study&#xD;
&#xD;
         12. Patients who regularly use daytime oxygen therapy for more than one hour per day and&#xD;
             in the investigator's opinion will be unable to abstain from the use of oxygen therapy&#xD;
&#xD;
         13. Patients who are being treated with antihistamines (H1 receptor antagonists),&#xD;
             antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic&#xD;
             conditions. See exclusion criterion No 6&#xD;
&#xD;
         14. Patients who have been treated with cromolyn sodium or nedocromil sodium within one&#xD;
             month prior to Visit 1 or during the run-in period&#xD;
&#xD;
         15. Patients using oral corticosteroid medication at unstable doses (i.e., less than six&#xD;
             weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone&#xD;
             per day or 20 mg every other day&#xD;
&#xD;
         16. Patients with known hypersensitivity to beta-adrenergics, lactose or any other&#xD;
             components of the inhalation capsule delivery system or the Diskus®&#xD;
&#xD;
         17. Pregnant or nursing women or women of childbearing potential not using a medically&#xD;
             approved means of contraception for the previous three months (i.e. oral&#xD;
             contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.:&#xD;
             Norplant®)&#xD;
&#xD;
         18. Patients who have taken an investigational drug within one month or six half lives&#xD;
             (whichever is greater) prior to Visit 1&#xD;
&#xD;
         19. Patients who have been treated with oral beta-adrenergics within one month prior to&#xD;
             Visit 1 or during the run-in period&#xD;
&#xD;
         20. Patients who have been treated with theophylline preparations within one month prior&#xD;
             to Visit 1 or during the run-in period&#xD;
&#xD;
         21. Patients who have been treated with the long-acting anticholinergic tiotropium&#xD;
             (Spiriva®) within one month prior to Visit 1 or during the run-in period&#xD;
&#xD;
         22. Patients with any respiratory infections in the six weeks prior to the Screening Visit&#xD;
             (Visit 1) or during the run-in period. In the case of a respiratory infection during&#xD;
             the run-in period the latter may be extended up to six weeks&#xD;
&#xD;
         23. Patients who are currently participating in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://clintriage.rdg@boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salmeterol Xinafoate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02238106
org study id: 1184.12
nct id: NCT02238106
lead sponsor: 
The primary objective of this trial was to establish non-inferiority of lung function
      response to two doses [25 μg (1 capsule) and 50 μg (2 capsules of 25 μg)] salmeterol,
      administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene
      (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg,
      administered as the xinafoate salt) following single dose inhalation in patients with COPD. A
      hard capsule with half the strength (12.5 μg) was included to investigate a dose ordering
      effect.

      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation
      powder delivered by HandiHaler® 2 from the PE hard capsule(s) and salmeterol xinafoate
      delivered by Serevent® Diskus®, and to compare the safety of the different pharmaceutical
      forms and/or doses.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Change in peak FEV1
time frame: within 3 hours post-dosing
description: Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing
measure: Change in peak forced vital capacity (FVC)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Change in FVC AUC0-12h
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Individual FEV1 measurements at each time point
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Individual FVC measurements at each time point
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: λz (terminal rate constant in plasma)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: t½ (terminal half-life of the analyte in plasma)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: MRTih (mean residence time of the analyte in the body after inhalational administration)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)
time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
measure: fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
measure: CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
measure: Number of patients with adverse events
time frame: up to 36 days
arm group label: Salmeterol inhalation powder, medium dose
arm group type: Experimental
description: administered via HandiHaler®
arm group label: Salmeterol inhalation powder, low dose
arm group type: Active Comparator
description: administered via HandiHaler®
arm group label: Salmeterol inhalation powder, high dose
arm group type: Active Comparator
description: administered via HandiHaler®
arm group label: Serevent® Diskus®
arm group type: Active Comparator
description: administered via Diskus®
arm group label: Placebo
arm group type: Placebo Comparator
description: administered via Diskus® or HandiHaler®
intervention type: Drug
intervention name: Salmeterol medium dose
arm group label: Salmeterol inhalation powder, medium dose
intervention type: Drug
intervention name: Salmeterol low dose
arm group label: Salmeterol inhalation powder, low dose
intervention type: Drug
intervention name: Salmeterol high dose
arm group label: Salmeterol inhalation powder, high dose
intervention type: Drug
intervention name: Serevent® Diskus®
arm group label: Serevent® Diskus®
intervention type: Drug
intervention name: Placebo HandiHaler®
arm group label: Placebo
arm group label: Salmeterol inhalation powder, low dose
arm group label: Salmeterol inhalation powder, medium dose
arm group label: Serevent® Diskus®
intervention type: Drug
intervention name: Placebo Diskus®
arm group label: Placebo
arm group label: Salmeterol inhalation powder, high dose
arm group label: Salmeterol inhalation powder, low dose
arm group label: Salmeterol inhalation powder, medium dose
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
url: http://clintriage.rdg@boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Salmeterol Xinafoate