<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/NCT01729247</url>
  </required_header>
  <id_info>
    <org_study_id>AER-043</org_study_id>
    <nct_id>NCT01729247</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerocrine AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerocrine AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.&#xD;
&#xD;
      Secondary objectives: Evaluate the ability of physicians to correctly assess airway&#xD;
      inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement).&#xD;
      Estimate the cost consequences of changes in asthma management following FeNO determinations&#xD;
&#xD;
      Number of participants: Approximately 40 to 50 subjects will participate in the study during&#xD;
      an (approximately) 8-12 week study enrollment period.&#xD;
&#xD;
      Reference product: NIOX MINO® Instrument (09-1100)&#xD;
&#xD;
      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be&#xD;
      performed according to the &quot;Perform FeNO Measurement&quot; guidelines on page 7 of the NIOX MINO®&#xD;
      User Manual (February, 2011).&#xD;
&#xD;
      Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4)&#xD;
      FeNO has been measured and seen by the Physician/Health Care Practitioner.&#xD;
&#xD;
      Safety assessments: The Investigator is responsible for the detection, reporting, and&#xD;
      documentation of events meeting the definition of an Adverse Event (AE) and/or Serious&#xD;
      Injuries as provided in this clinical investigation plan (CIP) from the time that informed&#xD;
      consent has been provided and during the study period&#xD;
&#xD;
      Criteria for evaluation: This is an observational, pilot study and there are currently no&#xD;
      plans for a formal statistical analysis. Information gained from this study may be used to&#xD;
      design subsequent studies in subjects with asthma. Data collected will be summarized in a&#xD;
      clinical study report but will not be subject to formal hypothesis testing&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      Overview:&#xD;
&#xD;
      The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway&#xD;
      inflammation that can be performed consistently and accurately in clinical practice at the&#xD;
      point-of-care. Airway inflammation is now recognized as the central mechanism in the&#xD;
      pathogenesis of asthma. The measurement of FeNO with the NIOX MINO® device provides a rapid,&#xD;
      noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway&#xD;
      diseases such as asthma. The test is easy to perform and requires minimal training for the&#xD;
      operator to conduct the test.&#xD;
&#xD;
      Role of Exhaled Nitric Oxide (FeNO):&#xD;
&#xD;
      FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric&#xD;
      oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part&#xD;
      of the inflammatory process.&#xD;
&#xD;
      Measuring the amount of FeNO is useful in the initial assessment of patients with chronic&#xD;
      cough or non-specific respiratory symptoms suggestive of asthma, and for the management of&#xD;
      patients with established asthma who are receiving corticosteroid treatment.&#xD;
&#xD;
      Intended Use:&#xD;
&#xD;
      NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased&#xD;
      in inflammatory processes such as asthma. The fractional NO concentration in expired breath&#xD;
      (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and&#xD;
      according to guidelines for NO measurement established by the American Thoracic Society.&#xD;
&#xD;
      Rationale for Study:&#xD;
&#xD;
      None of the standard clinical assessment tools provide information regarding underlying&#xD;
      airway inflammation, the control of which is central to an effective asthma management&#xD;
      strategy. Therefore this study will evaluate the impact of FeNO assessments on asthma&#xD;
      treatment decisions in approximately 40-50 subjects 7-60 years of age with asthma. This pilot&#xD;
      study will also provide information regarding the ability of physicians to correctly assess&#xD;
      airway inflammation using standard clinical assessment tools (i.e., prior to FeNO&#xD;
      measurement). Finally, this pilot study will allow the cost consequences of changes in asthma&#xD;
      management following FeNO determinations to be estimated.&#xD;
&#xD;
      CLINICAL INVESTIGATION OBJECTIVES The primary objective of this study is to evaluate the&#xD;
      impact of FeNO assessments on asthma treatment decisions.&#xD;
&#xD;
      The secondary objectives of this study are to:&#xD;
&#xD;
        -  Evaluate the ability of physicians to correctly assess airway inflammation using&#xD;
           standard clinical assessment tools (i.e., prior to FeNO measurement).&#xD;
&#xD;
        -  Estimate the cost consequences of changes in asthma management following FeNO&#xD;
           determinations.&#xD;
&#xD;
      CLINICAL INVESTIGATION PLAN&#xD;
&#xD;
      This is a pilot, observational, single-center, single-visit, outpatient study. Approximately&#xD;
      30 to 50 subjects will participate in the study during an (approximately) 8 to 12 week study&#xD;
      enrollment period. Eligible subjects who meet the inclusion/exclusion criteria for this study&#xD;
      will be invited to participate. The following documentation and information will be provided&#xD;
      by subjects:&#xD;
&#xD;
        -  Informed consent&#xD;
&#xD;
        -  Demographics&#xD;
&#xD;
        -  Smoking history (cigarettes only)&#xD;
&#xD;
        -  Usual asthma standard of care assessments&#xD;
&#xD;
        -  Asthma control test questionnaire&#xD;
&#xD;
        -  Spirometry&#xD;
&#xD;
        -  Study physician questions&#xD;
&#xD;
      FeNO: FeNO will be performed and the value will be reviewed and record.&#xD;
&#xD;
      Subject discharge from the study:&#xD;
&#xD;
      Once all information has been collected and all procedures have been performed, the subject&#xD;
      will be discharged from the clinic and their study participation will be complete&#xD;
&#xD;
      Medical device:&#xD;
&#xD;
      The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device&#xD;
      for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation.&#xD;
      The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which&#xD;
      will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in&#xD;
      adults 18 years of age or older in the initial assessment and management of asthma.&#xD;
&#xD;
      The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow&#xD;
      rate. Results are provided at the point of care within 2 minutes after the successful&#xD;
      completion of the breath test. The test cannot be influenced by patient effort or variations&#xD;
      in the clinician's test technique.&#xD;
&#xD;
      Definitions:&#xD;
&#xD;
      Adverse event: Any incident where the use of a medical device (including in vitro&#xD;
      diagnostics) is suspected to have resulted in an adverse outcome in a patient.&#xD;
&#xD;
      Serious Injury means injury or illness that:&#xD;
&#xD;
        -  Is life-threatening&#xD;
&#xD;
        -  Results in permanent impairment of a body function or permanent damage to a body&#xD;
           structure, or&#xD;
&#xD;
        -  Necessitates medical or surgical intervention to preclude permanent impairment of a body&#xD;
           function or permanent damage to a body structure.&#xD;
&#xD;
      Malfunction: the failure of a device to meet its performance specifications or otherwise&#xD;
      perform as intended.&#xD;
&#xD;
      Caused or contributed: the death or serious injury was or may have been attributed to a&#xD;
      medical device, or that the medical device was or may have been a factor in a death or&#xD;
      serious injury, including events occurring as a result of:&#xD;
&#xD;
        -  Failure&#xD;
&#xD;
        -  Malfunction&#xD;
&#xD;
        -  Improper or inadequate design&#xD;
&#xD;
        -  Manufacture&#xD;
&#xD;
        -  Labeling&#xD;
&#xD;
        -  User error&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>FeNO Values by ACT Score</measure>
    <time_frame>Study Visit (single visit study). Approximately 1 hour.</time_frame>
    <description>Scores on an asthma control test (ACT) of &lt;=19 indicates less well controlled asthma, scores &gt;19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FeNO Categorical Levels by ICS Use</measure>
    <time_frame>Study visit (single visit study). Approximately1 hour.</time_frame>
    <description>Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (&lt;25 ppb), intermediate (&gt;=25 to &lt;=50 ppb) and high (&gt;50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician Assessment of Airway Inflammation</measure>
    <time_frame>Study visit (single visit study) approximately 1 hour</time_frame>
    <description>Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Correctly Categorized by True Level of Airway Inflammation</measure>
    <time_frame>Study visit (single visit study) approximately 1 hour.</time_frame>
    <description>Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Management Changes After FeNO Results Were Considered</measure>
    <time_frame>Study visit (single visit study). Approximately1 hour.</time_frame>
    <description>Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>FeNO</arm_group_label>
    <description>Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIOX MINO® Instrument (09-1100)</intervention_name>
    <arm_group_label>FeNO</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female subjects, 7 to 60 years of age, inclusive, with asthma will be recruited&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 7 to 60 years of age, inclusive&#xD;
&#xD;
          -  Sex: Males and Females&#xD;
&#xD;
          -  Diagnosis: Asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent Conditions or Disease: Subjects with an established diagnosis of chronic,&#xD;
             obstructive pulmonary disease (COPD) cystic fibrosis (CF), bronchiectasis,&#xD;
             obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive&#xD;
             syndrome, or vocal cord dysfunction are excluded from participation&#xD;
&#xD;
          -  Cigarette Smoking: Subjects with greater than a 10 pack-year history of cigarette&#xD;
             smoking are excluded from participation&#xD;
&#xD;
          -  Study Participation Outside of This Protocol: Subjects currently enrolled in studies&#xD;
             of Investigational or Non-Investigational Drugs or Medical Devices and/or who&#xD;
             participated in these studies within 30 days prior to this study are excluded from&#xD;
             participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>North Carolina Clinical Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>November 27, 2013</results_first_submitted>
  <results_first_submitted_qc>January 15, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 3, 2014</results_first_posted>
  <last_update_submitted>January 15, 2014</last_update_submitted>
  <last_update_submitted_qc>January 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>FeNO</title>
          <description>Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FeNO</title>
          <description>Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </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="35.1" spread="15.81"/>
                  </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="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <description>At study visit, participants responded to a questionnaire regarding their smoking history. Participants were classified as having never smoked, current smoker, or past smoker.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Never Smoked</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Past Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Medications used for Pulmonary and/or Allergy Conditions</title>
          <description>Provided is a summary of medications taken by &gt;= 5% of participants that are used for pulmonary and/or allergy conditions. The most common medications included short-acting beta-agonist bronchodilators (SABA), inhaled corticosteroid (ICS) and long-acting beta-agonist bronchodilators (LABA) combination products, H1-receptor antagonist and ICS</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>SABA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICS/LABA Combination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1-Receptor Antagonist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antihistamine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intranasal Corticosteroid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukotriene Receptor Antagonist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Decongestant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>FeNO Values by ACT Score</title>
        <description>Scores on an asthma control test (ACT) of &lt;=19 indicates less well controlled asthma, scores &gt;19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.</description>
        <time_frame>Study Visit (single visit study). Approximately 1 hour.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low ACT Score</title>
            <description>Participants who had an asthma control test (ACT) score of &lt;=19, which indicates less well-controlled asthma</description>
          </group>
          <group group_id="O2">
            <title>High ACT Score</title>
            <description>Participants who had an asthma control test (ACT) score of &gt;19, which indicates well-controlled asthma</description>
          </group>
        </group_list>
        <measure>
          <title>FeNO Values by ACT Score</title>
          <description>Scores on an asthma control test (ACT) of &lt;=19 indicates less well controlled asthma, scores &gt;19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.</description>
          <units>parts per billion (ppb)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="50.84"/>
                    <measurement group_id="O2" value="26.3" spread="21.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FeNO Categorical Levels by ICS Use</title>
        <description>Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (&lt;25 ppb), intermediate (&gt;=25 to &lt;=50 ppb) and high (&gt;50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.</description>
        <time_frame>Study visit (single visit study). Approximately1 hour.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ICS Use</title>
            <description>Participants that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)</description>
          </group>
          <group group_id="O2">
            <title>No ICS Use</title>
            <description>Participants that did not use inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)</description>
          </group>
        </group_list>
        <measure>
          <title>FeNO Categorical Levels by ICS Use</title>
          <description>Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (&lt;25 ppb), intermediate (&gt;=25 to &lt;=50 ppb) and high (&gt;50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Low FeNO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate FeNO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High FeNO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Assessment of Airway Inflammation</title>
        <description>Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).</description>
        <time_frame>Study visit (single visit study) approximately 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Airway Inflammation</title>
            <description>As categorized by physician assessment</description>
          </group>
          <group group_id="O2">
            <title>Intermediate Airway Inflammation</title>
            <description>As categorized by physician assessment</description>
          </group>
          <group group_id="O3">
            <title>High Airway Inflammation</title>
            <description>As categorized by physician assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Assessment of Airway Inflammation</title>
          <description>Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).</description>
          <units>parts per billion (ppb)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" spread="38.16"/>
                    <measurement group_id="O2" value="40.6" spread="51.37"/>
                    <measurement group_id="O3" value="42.0" spread="25.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Correctly Categorized by True Level of Airway Inflammation</title>
        <description>Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.</description>
        <time_frame>Study visit (single visit study) approximately 1 hour.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Airway Inflammation</title>
            <description>As categorized by physician assessment</description>
          </group>
          <group group_id="O2">
            <title>Intermediate Airway Inflammation</title>
            <description>As categorized by physician assessment</description>
          </group>
          <group group_id="O3">
            <title>High Airway Inflammation</title>
            <description>As categorized by physician assessment</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Correctly Categorized by True Level of Airway Inflammation</title>
          <description>Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.</description>
          <units>participants correctly categorized</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Management Changes After FeNO Results Were Considered</title>
        <description>Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).</description>
        <time_frame>Study visit (single visit study). Approximately1 hour.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FeNO</title>
            <description>Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Management Changes After FeNO Results Were Considered</title>
          <description>Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No Changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Changes to SABA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Changes to ICS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Changes to ICS/LABA Combination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Changes to LTRA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study Visit (single visit study). Approximately 1 hour.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FeNO</title>
          <description>Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.</description>
        </group>
      </group_list>
      <serious_events>
        <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="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nancy Herje, BSN, RN, MBA</name_or_title>
      <organization>Aerocrine, Inc.</organization>
      <phone>919-449-8873</phone>
      <email>Nancy.Herje@aerocrine.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/NCT01729247
org study id: AER-043
nct id: NCT01729247
lead sponsor: 
has dmc: No
Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.

      Secondary objectives: Evaluate the ability of physicians to correctly assess airway
      inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement).
      Estimate the cost consequences of changes in asthma management following FeNO determinations

      Number of participants: Approximately 40 to 50 subjects will participate in the study during
      an (approximately) 8-12 week study enrollment period.

      Reference product: NIOX MINO® Instrument (09-1100)

      Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be
      performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO®
      User Manual (February, 2011).

      Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4)
      FeNO has been measured and seen by the Physician/Health Care Practitioner.

      Safety assessments: The Investigator is responsible for the detection, reporting, and
      documentation of events meeting the definition of an Adverse Event (AE) and/or Serious
      Injuries as provided in this clinical investigation plan (CIP) from the time that informed
      consent has been provided and during the study period

      Criteria for evaluation: This is an observational, pilot study and there are currently no
      plans for a formal statistical analysis. Information gained from this study may be used to
      design subsequent studies in subjects with asthma. Data collected will be summarized in a
      clinical study report but will not be subject to formal hypothesis testing
INTRODUCTION

      Overview:

      The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway
      inflammation that can be performed consistently and accurately in clinical practice at the
      point-of-care. Airway inflammation is now recognized as the central mechanism in the
      pathogenesis of asthma. The measurement of FeNO with the NIOX MINO® device provides a rapid,
      noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway
      diseases such as asthma. The test is easy to perform and requires minimal training for the
      operator to conduct the test.

      Role of Exhaled Nitric Oxide (FeNO):

      FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric
      oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part
      of the inflammatory process.

      Measuring the amount of FeNO is useful in the initial assessment of patients with chronic
      cough or non-specific respiratory symptoms suggestive of asthma, and for the management of
      patients with established asthma who are receiving corticosteroid treatment.

      Intended Use:

      NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased
      in inflammatory processes such as asthma. The fractional NO concentration in expired breath
      (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and
      according to guidelines for NO measurement established by the American Thoracic Society.

      Rationale for Study:

      None of the standard clinical assessment tools provide information regarding underlying
      airway inflammation, the control of which is central to an effective asthma management
      strategy. Therefore this study will evaluate the impact of FeNO assessments on asthma
      treatment decisions in approximately 40-50 subjects 7-60 years of age with asthma. This pilot
      study will also provide information regarding the ability of physicians to correctly assess
      airway inflammation using standard clinical assessment tools (i.e., prior to FeNO
      measurement). Finally, this pilot study will allow the cost consequences of changes in asthma
      management following FeNO determinations to be estimated.

      CLINICAL INVESTIGATION OBJECTIVES The primary objective of this study is to evaluate the
      impact of FeNO assessments on asthma treatment decisions.

      The secondary objectives of this study are to:

        -  Evaluate the ability of physicians to correctly assess airway inflammation using
           standard clinical assessment tools (i.e., prior to FeNO measurement).

        -  Estimate the cost consequences of changes in asthma management following FeNO
           determinations.

      CLINICAL INVESTIGATION PLAN

      This is a pilot, observational, single-center, single-visit, outpatient study. Approximately
      30 to 50 subjects will participate in the study during an (approximately) 8 to 12 week study
      enrollment period. Eligible subjects who meet the inclusion/exclusion criteria for this study
      will be invited to participate. The following documentation and information will be provided
      by subjects:

        -  Informed consent

        -  Demographics

        -  Smoking history (cigarettes only)

        -  Usual asthma standard of care assessments

        -  Asthma control test questionnaire

        -  Spirometry

        -  Study physician questions

      FeNO: FeNO will be performed and the value will be reviewed and record.

      Subject discharge from the study:

      Once all information has been collected and all procedures have been performed, the subject
      will be discharged from the clinic and their study participation will be complete

      Medical device:

      The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device
      for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation.
      The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which
      will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in
      adults 18 years of age or older in the initial assessment and management of asthma.

      The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow
      rate. Results are provided at the point of care within 2 minutes after the successful
      completion of the breath test. The test cannot be influenced by patient effort or variations
      in the clinician's test technique.

      Definitions:

      Adverse event: Any incident where the use of a medical device (including in vitro
      diagnostics) is suspected to have resulted in an adverse outcome in a patient.

      Serious Injury means injury or illness that:

        -  Is life-threatening

        -  Results in permanent impairment of a body function or permanent damage to a body
           structure, or

        -  Necessitates medical or surgical intervention to preclude permanent impairment of a body
           function or permanent damage to a body structure.

      Malfunction: the failure of a device to meet its performance specifications or otherwise
      perform as intended.

      Caused or contributed: the death or serious injury was or may have been attributed to a
      medical device, or that the medical device was or may have been a factor in a death or
      serious injury, including events occurring as a result of:

        -  Failure

        -  Malfunction

        -  Improper or inadequate design

        -  Manufacture

        -  Labeling

        -  User error
observational model: Case-Only
time perspective: Prospective
measure: FeNO Values by ACT Score
time frame: Study Visit (single visit study). Approximately 1 hour.
description: Scores on an asthma control test (ACT) of <=19 indicates less well controlled asthma, scores >19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.
measure: FeNO Categorical Levels by ICS Use
time frame: Study visit (single visit study). Approximately1 hour.
description: Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (<25 ppb), intermediate (>=25 to <=50 ppb) and high (>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.
measure: Physician Assessment of Airway Inflammation
time frame: Study visit (single visit study) approximately 1 hour
description: Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).
measure: Number of Participants Correctly Categorized by True Level of Airway Inflammation
time frame: Study visit (single visit study) approximately 1 hour.
description: Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.
measure: Asthma Management Changes After FeNO Results Were Considered
time frame: Study visit (single visit study). Approximately1 hour.
description: Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).
arm group label: FeNO
description: Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
intervention type: Device
intervention name: NIOX MINO® Instrument (09-1100)
arm group label: FeNO
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 