<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/NCT01730027</url>
  </required_header>
  <id_info>
    <org_study_id>ADC3680-07</org_study_id>
    <secondary_id>2012-003966-42</secondary_id>
    <nct_id>NCT01730027</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma</brief_title>
  <official_title>A Randomised, Double Blind, Placebo-Controlled, Multi-Centre, Parallel Group Study to Evaluate the Efficacy and Safety of ADC3680 Administered Once Daily as an Add-On Therapy to Inhaled Corticosteroids and When Co-Administered With Montelukast in Subjects With Inadequately-Controlled Asthma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pulmagen Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pulmagen Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety&#xD;
      of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when&#xD;
      co-administered with montelukast in patients with inadequately-controlled asthma. Patients&#xD;
      will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-centre, randomised, placebo-controlled, double blind, parallel group 3-arm&#xD;
      study (including montelukast as an active comparator) designed to compare the efficacy and&#xD;
      safety of a once daily dose of ADC3680 with placebo in subjects with inadequately-controlled&#xD;
      asthma despite receiving a low to moderate dose of an ICS controller therapy, over a 10 week&#xD;
      treatment period. At the end of the 10 week treatment period open label montelukast (10 mg)&#xD;
      will be added to ADC3680 and placebo arms for a two week extension period to assess whether&#xD;
      efficacy of ADC3680 is enhanced by the addition of montelukast compared with montelukast&#xD;
      alone. The montelukast arm will continue with 10 mg montelukast alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adding montelukast to ADC3680 in improving lung function (FEV1)</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of ADC3680 compared to placebo</measure>
    <time_frame>10 weeks</time_frame>
    <description>Safety evaluations will include incidence of Serious Adverse Events (from informed consent), severity &amp; frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from baseline to week 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of a 2 week administration of ADC3680 in combination with montelukast</measure>
    <time_frame>2 weeks</time_frame>
    <description>Safety evaluations will include incidence of Serious Adverse Events, severity &amp; frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from week 10 to week 12.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">248</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>ADC3680</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ADC3680 oral once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>montelukast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>montelukast oral once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADC3680</intervention_name>
    <description>ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period</description>
    <arm_group_label>ADC3680</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>montelukast</intervention_name>
    <description>montelukast for 12 weeks</description>
    <arm_group_label>montelukast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 years to 50 years (inclusive)&#xD;
&#xD;
          -  Diagnosis of asthma (GINA 2011) including a demonstration of reversible airway&#xD;
             obstruction&#xD;
&#xD;
          -  Pre-bronchodilator FEV1 value ≥ 40% and ≤ 85% of the predicted normal value at&#xD;
             baseline&#xD;
&#xD;
          -  A score of 1.5 or greater on the Asthma Control Questionnaire at baseline&#xD;
&#xD;
          -  Daily use of low to moderate dose of ICS (equivalent to budesonide ≤ 800 µg per day)&#xD;
&#xD;
          -  Prescribed a short-acting inhaled bronchodilator as reliever therapy for relief of&#xD;
             symptoms&#xD;
&#xD;
          -  A peripheral blood eosinophil count ≥ 0.25 x 109/L&#xD;
&#xD;
          -  Non-smoker or former smoker who has not smoked in the last six months&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 17 and ≤ 35 kg/m2&#xD;
&#xD;
          -  Able to comply with the protocol requirements, instructions and restrictions&#xD;
&#xD;
          -  Able to provide signed and dated written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with severe asthma exacerbation in the 4 weeks prior to consent&#xD;
&#xD;
          -  Subjects with respiratory tract infection in the 4 weeks prior to consent&#xD;
&#xD;
          -  Subjects with COPD or other relevant lung diseases&#xD;
&#xD;
          -  Subjects with clinically significant condition which may compromise subject safety or&#xD;
             interfere with study evaluation&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>922647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Rolling Hills</city>
        <state>California</state>
        <zip>90274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>6708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Eagle</city>
        <state>Idaho</state>
        <zip>83616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Nottingham</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bricktown</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigatinal Site</name>
      <address>
        <city>Clemmons</city>
        <state>North Carolina</state>
        <zip>27012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulamgen Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Maumee</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Fort Mill</city>
        <state>South Carolina</state>
        <zip>29707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Killeen</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investgational Site</name>
      <address>
        <city>Woodway</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Cakovec</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Sisak</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Varazdin</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Beroun</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Havlickuv Brod</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Holesov</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Jaromer</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Neratovice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Svitavy</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Teplice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Tremosna</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bad Worishofen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Deggingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Geesthacht</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Hagen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Schwerin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Teuchem</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Weyhe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Balassagyarmat</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Kaposvar</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Komlo</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Pecs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Szazhalombatta</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Szombathely</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bielsko Biala</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bienkowka</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Ostrow Wilekopolski</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Proszowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Skierniewice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Tarnow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulamgen Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Wilkowice-Bystra</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Zabrze</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmagen Investigational Site</name>
      <address>
        <city>Zgierz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <disposition_first_submitted>September 20, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>October 2, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 6, 2017</disposition_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Montelukast</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01730027
org study id: ADC3680-07
secondary id: 2012-003966-42
nct id: NCT01730027
lead sponsor: 
has dmc: No
This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety
      of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when
      co-administered with montelukast in patients with inadequately-controlled asthma. Patients
      will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.
This is a multi-centre, randomised, placebo-controlled, double blind, parallel group 3-arm
      study (including montelukast as an active comparator) designed to compare the efficacy and
      safety of a once daily dose of ADC3680 with placebo in subjects with inadequately-controlled
      asthma despite receiving a low to moderate dose of an ICS controller therapy, over a 10 week
      treatment period. At the end of the 10 week treatment period open label montelukast (10 mg)
      will be added to ADC3680 and placebo arms for a two week extension period to assess whether
      efficacy of ADC3680 is enhanced by the addition of montelukast compared with montelukast
      alone. The montelukast arm will continue with 10 mg montelukast alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
time frame: 10 weeks
measure: Adding montelukast to ADC3680 in improving lung function (FEV1)
time frame: 2 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
time frame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
time frame: 2 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
time frame: 6 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
time frame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
time frame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
time frame: 2 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
time frame: 6 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
time frame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
time frame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
time frame: 10 weeks
measure: Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
time frame: 2 weeks
measure: Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
time frame: 2 weeks
measure: Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
time frame: 2 weeks
measure: Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
time frame: 2 weeks
measure: Safety of ADC3680 compared to placebo
time frame: 10 weeks
description: Safety evaluations will include incidence of Serious Adverse Events (from informed consent), severity & frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from baseline to week 10.
measure: Safety of a 2 week administration of ADC3680 in combination with montelukast
time frame: 2 weeks
description: Safety evaluations will include incidence of Serious Adverse Events, severity & frequency of Adverse Events, change in laboratory values (haematology, clinical chemistry and urinalysis), change in vital signs (pulse, systolic and diastolic blood pressure), change in ECG and change in physical examination from week 10 to week 12.
arm group label: ADC3680
arm group type: Experimental
description: ADC3680 oral once daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo oral once daily
arm group label: montelukast
arm group type: Active Comparator
description: montelukast oral once daily
intervention type: Drug
intervention name: ADC3680
description: ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
arm group label: ADC3680
intervention type: Drug
intervention name: Placebo
description: Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
arm group label: Placebo
intervention type: Drug
intervention name: montelukast
description: montelukast for 12 weeks
arm group label: montelukast
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
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country: Croatia
country: Czechia
country: Germany
country: Hungary
country: Poland
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Asthma
mesh term: Montelukast