<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/NCT01720069</url>
  </required_header>
  <id_info>
    <org_study_id>VR506/2/004</org_study_id>
    <nct_id>NCT01720069</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma</brief_title>
  <official_title>A Randomised Double-blind, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of VR506 From a New Dry Powder Inhaler in Subjects With Severe Persistent Asthma Requiring Oral Corticosteroid Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vectura Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vectura Limited</source>
  <brief_summary>
    <textblock>
      To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using&#xD;
      oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily&#xD;
      regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent&#xD;
      asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative&#xD;
      for Asthma (GINA) guidelines 2011.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 2/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>Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)</measure>
    <time_frame>16 weeks</time_frame>
    <description>The mean asthma control prednisone/prednisolone dose at end of study (week 16)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score</measure>
    <time_frame>Baseline and 16 weeks</time_frame>
    <description>To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Withdrawals Due to Worsening of Asthma</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Acceptability of the Device</measure>
    <time_frame>16 weeks</time_frame>
    <description>Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Dose 1 VR506</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VR506 inhalation powder delivered via a new dry powder inhaler device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2 VR506</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VR506 inhalation powder delivered via a new dry powder inhaler device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 3 VR506</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VR506 inhalation powder delivered via a new dry powder inhaler device</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VR506</intervention_name>
    <description>VR506 inhalation powder delivered via a new dry powder inhaler device</description>
    <arm_group_label>Dose 1 VR506</arm_group_label>
    <arm_group_label>Dose 2 VR506</arm_group_label>
    <arm_group_label>Dose 3 VR506</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Adolescents aged 12-17 years &amp; adults aged 18-65 years (both inclusive)&#xD;
&#xD;
          -  Documented clinical history of severe asthma requiring prednisone/prednisolone&#xD;
             therapy, high-intensity treatment ICS, OCS, LABA&#xD;
&#xD;
          -  Stable OCS dose for ≥7 days before Screening Visit &amp; during Screening Period.&#xD;
&#xD;
          -  At least 80% compliant w/regular asthma medication per investigator at end of&#xD;
             Screening Period&#xD;
&#xD;
          -  Documented asthma reversibility within 5 yrs prior to/during Screening Period, or&#xD;
             diagnosis of asthma that is incontrovertible per investigator&#xD;
&#xD;
          -  Ability to use nDPI correctly, per investigator's review of completed inhaler&#xD;
             operation checklist&#xD;
&#xD;
          -  Ability to use eDiary correctly, assessed by investigator at end of Screening Period&#xD;
&#xD;
          -  Ability to comply w/study procedures, including blood sampling&#xD;
&#xD;
          -  Ability to perform technically satisfactory pulmonary function tests&#xD;
&#xD;
          -  Available to complete all study visits before 12 noon&#xD;
&#xD;
          -  BMI of 16-26 kg/m2 in adolescents and 18-32 kg/m2 in adults&#xD;
&#xD;
          -  Oral PIF ≥40 L/min, using an appropriate device set to match resistance of inhaler&#xD;
&#xD;
          -  Good health, except for presence of asthma, per medical history/physical examination&#xD;
&#xD;
          -  Negative drug/alcohol/urine cotinine screen. Subjects must test negative for&#xD;
             amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, ethanol&#xD;
             &amp; opiates (unless given as prescription medicine)&#xD;
&#xD;
          -  Non-smokers or ex-smokers with a smoking history of less than 10 pack-yrs (e.g. &lt;20&#xD;
             cigarettes per day for 10 years or &lt;40 cigarettes per day for 5 years) &amp; stopped&#xD;
             smoking for at least 1 year prior to Screening Visit. Smoking will not be permitted&#xD;
             throughout study&#xD;
&#xD;
          -  Female subjects of child-bearing potential must be using medically acceptable forms of&#xD;
             contraception [abstinence, hormonal (oral/implant/transdermal/injection), in use for&#xD;
             ≥3 consecutive months before first dose of study medication, double barrier (condom&#xD;
             w/spermicide, or diaphragm w/spermicide), IUD, or vasectomised partner (≥6 months&#xD;
             since vasectomy)].&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Regular use (≥3 times/wk) of topical steroids to treat dermatitis/rhinitis/allergic&#xD;
             conjunctivitis, within 28 days of Screening Visit&#xD;
&#xD;
          -  Subjects who have/who have had, an upper/lower respiratory tract infection within 28&#xD;
             days of Screening Visit&#xD;
&#xD;
          -  Subjects w/&quot;brittle asthma&#xD;
&#xD;
          -  Subjects w/asthma that required admission to an ICU and/or ventilation within previous&#xD;
             12 months&#xD;
&#xD;
          -  Subjects whose comorbidities, per investigator's opinion, are major contributors to&#xD;
             their respiratory symptoms (e.g. COPD, bronchiectasis, dysfunctional breathlessness,&#xD;
             vocal cord dysfunction, gastro-oesophageal reflux)&#xD;
&#xD;
          -  Previously/currently diagnosed as having Churg-Strauss syndrome&#xD;
&#xD;
          -  Previously/currently diagnosed as having pulmonary eosinophilia&#xD;
&#xD;
          -  History of lung cancer&#xD;
&#xD;
          -  Subjects w/current diagnosis of HIV infection&#xD;
&#xD;
          -  Active chronic hepatitis B or C infection&#xD;
&#xD;
          -  Subjects who have clinically significant abnormality/finding from examination, tests,&#xD;
             or history that may compromise subject safety, specifically any history of cardiac,&#xD;
             renal or hepatic impairment&#xD;
&#xD;
          -  Subjects with an abnormal ECG&#xD;
&#xD;
          -  Persistent arterial hypotension, with average SBP readings of ≤95 mmHg&#xD;
&#xD;
          -  Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or&#xD;
             average DBP readings of ≥100 mmHg&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Participation in another clinical study in 28 days prior to Screening Visit&#xD;
&#xD;
          -  Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from&#xD;
             asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis,&#xD;
             uncorrectable hypokalaemia, or predisposition to low levels of serum potassium&#xD;
&#xD;
          -  Current/history of drug/alcohol abuse/dependence per WHO criteria&#xD;
&#xD;
          -  Inability to communicate well w/investigator&#xD;
&#xD;
          -  Donation of ≥450 mL of blood/blood products within previous 3 months prior to&#xD;
             screening&#xD;
&#xD;
          -  History of allergy/intolerance/contraindications to corticosteroids/lactose, or severe&#xD;
             allergy to milk proteins&#xD;
&#xD;
          -  Consumption of alcohol- or caffeine-containing foods/beverages from midnight before or&#xD;
             during Screening Visit&#xD;
&#xD;
          -  History of medically diagnosed chronic respiratory diseases other than asthma (e.g.&#xD;
             chronic obstructive pulmonary disease, ABPA in the absence of asthma)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01001</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinial Trial Site 01005</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01006</name>
      <address>
        <city>Celebration</city>
        <state>Florida</state>
        <zip>34747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01015</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01012</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01014</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01003</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01011</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-1093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01013</name>
      <address>
        <city>Jersey City</city>
        <state>New Jersey</state>
        <zip>07306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01004</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 01007</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79925</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08006</name>
      <address>
        <city>Ruse</city>
        <zip>7000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08005</name>
      <address>
        <city>Sofia</city>
        <zip>1000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08001</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08003</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08007</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08004</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08002</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 08008</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03006</name>
      <address>
        <city>Berlin</city>
        <zip>10717</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03009</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03004</name>
      <address>
        <city>Bonn</city>
        <zip>53119</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03008</name>
      <address>
        <city>Donaustauf</city>
        <zip>93093</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03003</name>
      <address>
        <city>Dortmund</city>
        <zip>44263</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03007</name>
      <address>
        <city>Geesthacht</city>
        <zip>21502</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03001</name>
      <address>
        <city>Hamburg</city>
        <zip>22767</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03005</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 03002</name>
      <address>
        <city>Rudersdorf</city>
        <zip>15562</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 04001</name>
      <address>
        <city>Budapest</city>
        <zip>1121</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 04004</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 04003</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 04002</name>
      <address>
        <city>Rakoczi</city>
        <zip>125 127</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 04005</name>
      <address>
        <city>Rakoczi</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05008</name>
      <address>
        <city>Bialystok</city>
        <zip>15-003</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05002</name>
      <address>
        <city>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05010</name>
      <address>
        <city>Bialystok</city>
        <zip>15-430</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05011</name>
      <address>
        <city>Krakow</city>
        <zip>31-024</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05001</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05006</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05005</name>
      <address>
        <city>Lublin</city>
        <zip>20-552</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05007</name>
      <address>
        <city>Tarnow</city>
        <zip>33-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05003</name>
      <address>
        <city>Warszawa</city>
        <zip>02-097</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05009</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-162</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 05004</name>
      <address>
        <city>Zawadzkie</city>
        <zip>47-120</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07001</name>
      <address>
        <city>Brasov</city>
        <zip>500086</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07008</name>
      <address>
        <city>Bucuresti</city>
        <zip>010457</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07005</name>
      <address>
        <city>Bucuresti</city>
        <zip>020671</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07013</name>
      <address>
        <city>Bucuresti</city>
        <zip>030303</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07003</name>
      <address>
        <city>Bucuresti</city>
        <zip>050554</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07006</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07007</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07009</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07010</name>
      <address>
        <city>Cod</city>
        <zip>700115</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07014</name>
      <address>
        <city>Craiova</city>
        <zip>200515</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07002</name>
      <address>
        <city>Iasi</city>
        <zip>700376</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07004</name>
      <address>
        <city>Marghita</city>
        <zip>415300</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 07012</name>
      <address>
        <city>Targu Mures</city>
        <zip>540543</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinicl Trial Site 07011</name>
      <address>
        <city>Timis</city>
        <zip>300310</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06013</name>
      <address>
        <city>AR Crimea</city>
        <zip>97403</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06009</name>
      <address>
        <city>Donetsk</city>
        <zip>83099</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06012</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06010</name>
      <address>
        <city>Kharkiv</city>
        <zip>61002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06001</name>
      <address>
        <city>Kharkiv</city>
        <zip>61035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06004</name>
      <address>
        <city>Kharkiv</city>
        <zip>61106</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06006</name>
      <address>
        <city>Kyiv</city>
        <zip>02232</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06002</name>
      <address>
        <city>Kyiv</city>
        <zip>03680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06015</name>
      <address>
        <city>Kyiv</city>
        <zip>3680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06003</name>
      <address>
        <city>Kyviv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06008</name>
      <address>
        <city>Mykolaiv</city>
        <zip>54003</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06011</name>
      <address>
        <city>Vinnitsa</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06007</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 06014</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69118</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 02003</name>
      <address>
        <city>Cottingham</city>
        <state>Hull</state>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial site 02002</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 02004</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 02001</name>
      <address>
        <city>Newcastle</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vectura Clinical Trial Site 02005</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>March 19, 2020</results_first_submitted>
  <results_first_submitted_qc>April 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2020</results_first_posted>
  <disposition_first_submitted>September 11, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>September 11, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 22, 2014</disposition_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>197 subjects were randomised and 196 received at least one dose of study drug; 1 subject was randomised but not treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dose 1 VR506 50 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="P2">
          <title>Dose 2 VR506 250 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="P3">
          <title>Dose 3 VR506 500 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Anaylsis Set</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Could not use e-diary correctly</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>Randomised without baseline values</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Treatment period withdrawal criteria met</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>OCS bursts occured, discontinued in line</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>Non-compliance on using e-diary</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dose 1 VR506 50 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="B2">
          <title>Dose 2 VR506 250 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="B3">
          <title>Dose 3 VR506 500 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="B4">
          <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="62"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="63"/>
            <count group_id="B4" value="196"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="40"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="69"/>
                  </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>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)</title>
        <description>The mean asthma control prednisone/prednisolone dose at end of study (week 16)</description>
        <time_frame>16 weeks</time_frame>
        <population>The Full Analysis Set (FAS) was analyzed, however 7 subjects are not included because they had no OCS dose adjustment assessment post-randomisation, and baseline values were not carried forward.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)</title>
          <description>The mean asthma control prednisone/prednisolone dose at end of study (week 16)</description>
          <population>The Full Analysis Set (FAS) was analyzed, however 7 subjects are not included because they had no OCS dose adjustment assessment post-randomisation, and baseline values were not carried forward.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="6.85"/>
                    <measurement group_id="O2" value="4.31" spread="7.38"/>
                    <measurement group_id="O3" value="3.97" spread="6.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.772</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)</title>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)</title>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.4"/>
                    <measurement group_id="O2" value="0.02" spread="0.31"/>
                    <measurement group_id="O3" value="0.06" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.891</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score</title>
        <description>Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <population>Full Analysis Set was analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 1 subject had no post-dose ACQ-5 assessment, baseline value was not carried forward.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score</title>
          <description>Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).</description>
          <population>Full Analysis Set was analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 1 subject had no post-dose ACQ-5 assessment, baseline value was not carried forward.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="0.98"/>
                    <measurement group_id="O2" value="-0.77" spread="1.15"/>
                    <measurement group_id="O3" value="-0.39" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.066</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)</title>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)</title>
          <units>L/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="45.7"/>
                    <measurement group_id="O2" value="20.1" spread="51.7"/>
                    <measurement group_id="O3" value="6.1" spread="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.063</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score</title>
        <description>To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).</description>
        <time_frame>Baseline and 16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score</title>
          <description>To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1"/>
                    <measurement group_id="O2" value="-0.6" spread="1"/>
                    <measurement group_id="O3" value="-0.2" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.054</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Withdrawals Due to Worsening of Asthma</title>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Withdrawals Due to Worsening of Asthma</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.168</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.363</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.805</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Acceptability of the Device</title>
        <description>Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 VR506 50 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 VR506 250 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 VR506 500 mcg</title>
            <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Acceptability of the Device</title>
          <description>Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="71"/>
                <count group_id="O3" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fairly easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dose 1 VR506 50 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="E2">
          <title>Dose 2 VR506 250 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
        <group group_id="E3">
          <title>Dose 3 VR506 500 mcg</title>
          <description>VR506 inhalation powder delivered via a new dry powder inhaler device&#xD;
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (14.0)</default_vocab>
        <default_assessment>Non-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="21" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Middle Ear Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Food Poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Phyaryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Cystisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oropharyngitis Fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pharyngitis Streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection Viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tonsillitis Streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Viral Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint Sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Radiculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </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="15" subjects_affected="12" subjects_at_risk="62"/>
                <counts group_id="E2" events="35" subjects_affected="26" subjects_at_risk="71"/>
                <counts group_id="E3" events="16" subjects_affected="12" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Painful Respiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pharyngeal Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth Extraction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="63"/>
              </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>The terms and conditions of Vectura's agreements with its investigators may vary. Publication may be delayed for Sponsor review and revisions/deletions can be required. Furthermore, a delay to publication may be required by the Sponsor in order to take steps to protect its proprietary information and/or intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gary Burgess, MD</name_or_title>
      <organization>Vectura Limited</organization>
      <phone>+44(0)1249 667700</phone>
      <email>clinical.enquiries@vectura.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/NCT01720069
org study id: VR506/2/004
nct id: NCT01720069
lead sponsor: 
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using
      oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily
      regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent
      asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative
      for Asthma (GINA) guidelines 2011.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
time frame: 16 weeks
description: The mean asthma control prednisone/prednisolone dose at end of study (week 16)
measure: Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
time frame: Baseline and 16 weeks
measure: Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score
time frame: Baseline and 16 weeks
description: Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).
measure: Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
time frame: Baseline and 16 weeks
measure: Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score
time frame: Baseline and 16 weeks
description: To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).
measure: Number of Participants With Withdrawals Due to Worsening of Asthma
time frame: 16 weeks
measure: Assessment of Acceptability of the Device
time frame: 16 weeks
description: Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
arm group label: Dose 1 VR506
arm group type: Active Comparator
description: VR506 inhalation powder delivered via a new dry powder inhaler device
arm group label: Dose 2 VR506
arm group type: Active Comparator
description: VR506 inhalation powder delivered via a new dry powder inhaler device
arm group label: Dose 3 VR506
arm group type: Active Comparator
description: VR506 inhalation powder delivered via a new dry powder inhaler device
intervention type: Drug
intervention name: VR506
description: VR506 inhalation powder delivered via a new dry powder inhaler device
arm group label: Dose 1 VR506
arm group label: Dose 2 VR506
arm group label: Dose 3 VR506
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
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country: Bulgaria
country: Germany
country: Hungary
country: Poland
country: Romania
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Asthma
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