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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003966-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC3680 | Experimental | ADC3680 oral once daily |
|
| Placebo | Placebo Comparator | Placebo oral once daily |
|
| montelukast | Active Comparator | montelukast oral once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC3680 | Drug | ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ADC3680 compared with placebo in improving lung function (FEV1) | 10 weeks | |
| Adding montelukast to ADC3680 in improving lung function (FEV1) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10 | 10 weeks | |
| Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmagen Investigational Site | Birmingham | Alabama | United States | |||
| Pulmagen Investigational Site |
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| Placebo |
| Drug |
Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period |
|
| montelukast | Drug | montelukast for 12 weeks |
|
| 2 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6 | 6 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10 | 10 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10 | 10 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2 | 2 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6 | 6 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10 | 10 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10 | 10 weeks |
| Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10 | 10 weeks |
| Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12 | 2 weeks |
| Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12 | 2 weeks |
| Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12 | 2 weeks |
| Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12 | 2 weeks |
| Safety of ADC3680 compared to placebo | 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. | 10 weeks |
| Safety of a 2 week administration of ADC3680 in combination with montelukast | 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. | 2 weeks |
| Huntington Beach |
| California |
| 922647 |
| United States |
| Pulmagen Investigational Site | Riverside | California | United States |
| Pulmagen Investigational Site | Rolling Hills | California | 90274 | United States |
| Pulmagen Investigational Site | San Jose | California | United States |
| Pulmagen Investigational Site | Colorado Springs | Colorado | United States |
| Pulmagen Investigational Site | Waterbury | Connecticut | 6708 | United States |
| Pulmagen Investigational Site | Lawrenceville | Georgia | 30046 | United States |
| Pulmagen Investigational Site | Eagle | Idaho | 83616 | United States |
| Pulmagen Investigational Site | Nottingham | Maryland | 21236 | United States |
| Pulmagen Investigational Site | Plymouth | Minnesota | United States |
| Pulmagen Investigational Site | Bellevue | Nebraska | 68123 | United States |
| Pulmagen Investigational Site | Brick | New Jersey | United States |
| Pulmagen Investigatinal Site | Clemmons | North Carolina | 27012 | United States |
| Pulmagen Investigational Site | Canton | Ohio | United States |
| Pulamgen Investigational Site | Cincinnati | Ohio | 45231 | United States |
| Pulmagen Investigational Site | Maumee | Ohio | United States |
| Pulmagen Investigational Site | Oklahoma City | Oklahoma | United States |
| Pulmagen Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Pulmagen Investigational Site | Medford | Oregon | United States |
| Pulmagen Investigational Site | Portland | Oregon | United States |
| Pulmagen Investigational Site | East Providence | Rhode Island | United States |
| Pulmagen Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pulmagen Investigational Site | Charleston | South Carolina | United States |
| Pulmagen Investigational Site | Fort Mill | South Carolina | 29707 | United States |
| Pulmagen Investigational Site | Arlington | Texas | United States |
| Pulmagen Investigational Site | Austin | Texas | United States |
| Pulmagen Investigational Site | Houston | Texas | 77099 | United States |
| Pulmagen Investigational Site | Killeen | Texas | United States |
| Pulmagen Investigational Site | Waco | Texas | United States |
| Pulmagen Investgational Site | Woodway | Texas | 76712 | United States |
| Pulmagen Investigational Site | Draper | Utah | United States |
| Pulmagen Investigational Site | Seattle | Washington | United States |
| Pulmagen Investigational Site | Tacoma | Washington | 98405 | United States |
| Pulmagen Investigational Site | Greenfield | Wisconsin | United States |
| Pulmagen Investigational Site | Čakovec | Croatia |
| Pulmagen Investigational Site | Sisak | Croatia |
| Pulmagen Investigational Site | Varaždin | Croatia |
| Pulmagen Investigational Site | Zagreb | Croatia |
| Pulmagen Investigational Site | Beroun | Czechia |
| Pulmagen Investigational Site | Brno | Czechia |
| Pulmagen Investigational Site | Havlíčkův Brod | Czechia |
| Pulmagen Investigational Site | Holešov | Czechia |
| Pulmagen Investigational Site | Jaroměř | Czechia |
| Pulmagen Investigational Site | Neratovice | Czechia |
| Pulmagen Investigational Site | Svitavy | Czechia |
| Pulmagen Investigational Site | Teplice | Czechia |
| Pulmagen Investigational Site | Třemošná | Czechia |
| Pulmagen Investigational Site | Augsburg | Germany |
| Pulmagen Investigational Site | Bad Wörishofen | Germany |
| Pulmagen Investigational Site | Berlin | Germany |
| Pulmagen Investigational Site | Bonn | Germany |
| Pulmagen Investigational Site | Deggingen | Germany |
| Pulmagen Investigational Site | Dresden | Germany |
| Pulmagen Investigational Site | Geesthacht | Germany |
| Pulmagen Investigational Site | Hagen | Germany |
| Pulmagen Investigational Site | Hamburg | Germany |
| Pulmagen Investigational Site | Hanover | Germany |
| Pulmagen Investigational Site | Marburg | Germany |
| Pulmagen Investigational Site | Schwerin | Germany |
| Pulmagen Investigational Site | Teuchem | Germany |
| Pulmagen Investigational Site | Weyhe | Germany |
| Pulmagen Investigational Site | Balassagyarmat | Hungary |
| Pulmagen Investigational Site | Budapest | Hungary |
| Pulmagen Investigational Site | Kaposvár | Hungary |
| Pulmagen Investigational Site | Komló | Hungary |
| Pulmagen Investigational Site | Pécs | Hungary |
| Pulmagen Investigational Site | Százhalombatta | Hungary |
| Pulmagen Investigational Site | Szombathely | Hungary |
| Pulmagen Investigational Site | Bialystok | Poland |
| Pulmagen Investigational Site | Bielsko-Biala | Poland |
| Pulmagen Investigational Site | Bieńkówka | Poland |
| Pulmagen Investigational Site | Bydgoszcz | Poland |
| Pulmagen Investigational Site | Kielce | Poland |
| Pulmagen Investigational Site | Krakow | Poland |
| Pulmagen Investigational Site | Lodz | Poland |
| Pulmagen Investigational Site | Olsztyn | Poland |
| Pulmagen Investigational Site | Ostrow Wilekopolski | Poland |
| Pulmagen Investigational Site | Poznan | Poland |
| Pulmagen Investigational Site | Proszowice | Poland |
| Pulmagen Investigational Site | Skierniewice | Poland |
| Pulmagen Investigational Site | Tarnów | Poland |
| Pulamgen Investigational Site | Warsaw | Poland |
| Pulmagen Investigational Site | Wilkowice-Bystra | Poland |
| Pulmagen Investigational Site | Wroclaw | Poland |
| Pulmagen Investigational Site | Zabrze | Poland |
| Pulmagen Investigational Site | Zgierz | Poland |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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