A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Asthma |
Intervention | Drug: ADC3680 Drug: Placebo Drug: montelukast |
Phase | Phase 2 |
Sponsor | Pulmagen Therapeutics |
Responsible Party | Pulmagen Therapeutics |
ClinicalTrials.gov Identifier | NCT01730027 |
First Received | November 9, 2012 |
Last Updated | March 21, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | November 9, 2012 |
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Last Updated Date | March 21, 2014 |
Start Date | April 2013 |
Estimated Primary Completion Date | November 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma |
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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. |
Brief Summary | 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Asthma |
Intervention | Drug: ADC3680 ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period Drug: Placebo Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period Drug: montelukast montelukast for 12 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 330 |
Estimated Completion Date | November 2014 |
Estimated Primary Completion Date | June 2014 |
Eligibility Criteria | Inclusion Criteria: - Men and women aged 18 years to 50 years (inclusive) - Diagnosis of asthma (GINA 2011) including a demonstration of reversible airway obstruction - Pre-bronchodilator FEV1 value ≥ 40% and ≤ 85% of the predicted normal value at baseline - A score of 1.5 or greater on the Asthma Control Questionnaire at baseline - Daily use of low to moderate dose of ICS (equivalent to budesonide ≤ 800 µg per day) - Prescribed a short-acting inhaled bronchodilator as reliever therapy for relief of symptoms - A peripheral blood eosinophil count ≥ 0.25 x 109/L - Non-smoker or former smoker who has not smoked in the last six months - Body mass index (BMI) ≥ 17 and ≤ 35 kg/m2 - Able to comply with the protocol requirements, instructions and restrictions - Able to provide signed and dated written informed consent Exclusion Criteria: - Subjects with severe asthma exacerbation in the 4 weeks prior to consent - Subjects with respiratory tract infection in the 4 weeks prior to consent - Subjects with COPD or other relevant lung diseases - Subjects with clinically significant condition which may compromise subject safety or interfere with study evaluation Other protocol-defined inclusion/exclusion criteria may apply. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Mary Fitzgerald info@pulmagen.com |
Location Countries | United States, Croatia, Czech Republic, Germany, Hungary, Poland |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01730027 |
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Other Study ID Numbers | ADC3680-07 |
Has Data Monitoring Committee | No |
Information Provided By | Pulmagen Therapeutics |
Study Sponsor | Pulmagen Therapeutics |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
Pulmagen Investigational Site | Birmingham, Alabama, United States Recruiting |
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Pulmagen Investigational Site | Huntington Beach, California, United States, 922647 Recruiting |
Pulmagen Investigational Site | Riverside, California, United States Recruiting |
Pulmagen Investigational Site | Rolling Hill, California, United States, 90274 Recruiting |
Pulmagen Investigational Site | San Jose, California, United States Recruiting |
Pulmagen Investigational Site | Colorado Springs, Colorado, United States Recruiting |
Pulmagen Investigational Site | Waterbury, Connecticut, United States, 6708 Recruiting |
Pulmagen Investigational Site | Lawrenceville, Georgia, United States, 30046 Recruiting |
Pulmagen Investigational Site | Eagle, Idaho, United States, 83616 Recruiting |
Pulmagen Investigational Site | Nottingham, Maryland, United States, 21236 Recruiting |
Pulmagen Investigational Site | Plymouth, Minnesota, United States Recruiting |
Pulmagen Investigational Site | Bellevue, Nebraska, United States, 68123 Recruiting |
Pulmagen Investigational Site | Brick, New Jersey, United States Recruiting |
Pulmagen Investigatinal Site | Clemmos, North Carolina, United States, 27012 Recruiting |
Pulmagen Investigational Site | Canton, Ohio, United States Recruiting |
Pulamgen Investigational Site | Cincinnati, Ohio, United States, 45231 Recruiting |
Pulmagen Investigational Site | Maumee, Ohio, United States Recruiting |
Pulmagen Investigational Site | Oklahoma City, Oklahoma, United States Recruiting |
Pulmagen Investigational Site | Tulsa, Oklahoma, United States, 74136 Recruiting |
Pulmagen Investigational Site | Medford, Oregon, United States Recruiting |
Pulmagen Investigational Site | Portland, Oregon, United States Recruiting |
Pulmagen Investigational Site | East Providence, Rhode Island, United States Recruiting |
Pulmagen Investigational Site | Warwick, Rhode Island, United States, 02886 Recruiting |
Pulmagen Investigational Site | Charleston, South Carolina, United States Recruiting |
Pulmagen Investigational Site | Fort Mill, South Carolina, United States, 29707 Recruiting |
Pulmagen Investigational Site | Arlington, Texas, United States Recruiting |
Pulmagen Investigational Site | Austin, Texas, United States Recruiting |
Pulmagen Investigational Site | Houston, Texas, United States, 77099 Recruiting |
Pulmagen Investigational Site | Killeen, Texas, United States Recruiting |
Pulmagen Investigational Site | Waco, Texas, United States Recruiting |
Pulmagen Investgational Site | Woodway, Texas, United States, 76712 Recruiting |
Pulmagen Investigational Site | Draper, Utah, United States Recruiting |
Pulmagen Investigational Site | Seattle, Washington, United States Recruiting |
Pulmagen Investigational Site | Tacoma, Washington, United States, 98405 Recruiting |
Pulmagen Investigational Site | Greenfield, Wisconsin, United States Recruiting |
Pulmagen Investigational Site | Cakovec, Croatia Recruiting |
Pulmagen Investigational Site | Sisak, Croatia Recruiting |
Pulmagen Investigational Site | Varazdin, Croatia Recruiting |
Pulmagen Investigational Site | Zagreb, Croatia Recruiting |
Pulmagen Investigational Site | Beroun, Czech Republic Recruiting |
Pulmagen Investigational Site | Brno, Czech Republic Recruiting |
Pulmagen Investigational Site | Havlickuv Brod, Czech Republic Recruiting |
Pulmagen Investigational Site | Holesov, Czech Republic Recruiting |
Pulmagen Investigational Site | Jaromer, Czech Republic Recruiting |
Pulmagen Investigational Site | Neratovice, Czech Republic Recruiting |
Pulmagen Investigational Site | Svitavy, Czech Republic Recruiting |
Pulmagen Investigational Site | Teplice, Czech Republic Recruiting |
Pulmagen Investigational Site | Tremosna, Czech Republic Recruiting |
Pulmagen Investigational Site | Augsburg, Germany Recruiting |
Pulmagen Investigational Site | Bad Worishofen, Germany Recruiting |
Pulmagen Investigational Site | Berlin, Germany Recruiting |
Pulmagen Investigational Site | Bonn, Germany Recruiting |
Pulmagen Investigational Site | Deggingen, Germany Recruiting |
Pulmagen Investigational Site | Dresden, Germany Recruiting |
Pulmagen Investigational Site | Geesthacht, Germany Recruiting |
Pulmagen Investigational Site | Hagen, Germany Recruiting |
Pulmagen Investigational Site | Hamburg, Germany Recruiting |
Pulmagen Investigational Site | Hannover, Germany Recruiting |
Pulmagen Investigational Site | Marburg, Germany Recruiting |
Pulmagen Investigational Site | Schwerin, Germany Recruiting |
Pulmagen Investigational Site | Teuchem, Germany Recruiting |
Pulmagen Investigational Site | Weyhe, Germany Recruiting |
Pulmagen Investigational Site | Balassagyarmat, Hungary Recruiting |
Pulmagen Investigational Site | Budapest, Hungary Recruiting |
Pulmagen Investigational Site | Kaposvar, Hungary Recruiting |
Pulmagen Investigational Site | Komlo, Hungary Recruiting |
Pulmagen Investigational Site | Pecs, Hungary Recruiting |
Pulmagen Investigational Site | Szazhalombatta, Hungary Recruiting |
Pulmagen Investigational Site | Szombathely, Hungary Recruiting |
Pulmagen Investigational Site | Bialystok, Poland Recruiting |
Pulmagen Investigational Site | Bielsko Biala, Poland Recruiting |
Pulmagen Investigational Site | Bienkowka, Poland Recruiting |
Pulmagen Investigational Site | Bydgoszcz, Poland Recruiting |
Pulmagen Investigational Site | Kielce, Poland Recruiting |
Pulmagen Investigational Site | Krakow, Poland Recruiting |
Pulmagen Investigational Site | Lodz, Poland Recruiting |
Pulmagen Investigational Site | Olsztyn, Poland Recruiting |
Pulmagen Investigational Site | Ostrow Wilekopolski, Poland Recruiting |
Pulmagen Investigational Site | Poznan, Poland Recruiting |
Pulmagen Investigational Site | Proszowice, Poland Recruiting |
Pulmagen Investigational Site | Skierniewice, Poland Recruiting |
Pulmagen Investigational Site | Tarnow, Poland Recruiting |
Pulamgen Investigational Site | Warszawa, Poland Recruiting |
Pulmagen Investigational Site | Wilkowice-Bystra, Poland Recruiting |
Pulmagen Investigational Site | Wroclaw, Poland Recruiting |
Pulmagen Investigational Site | Zabrze, Poland Recruiting |
Pulmagen Investigational Site | Zgierz, Poland Recruiting |