Clinical trial NCT01730027: A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Pulmagen Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
timeFrame: 10 weeks
measure: Adding montelukast to ADC3680 in improving lung function (FEV1)
timeFrame: 2 weeks
Secondary outcomes:
measure: Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
timeFrame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
timeFrame: 2 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
timeFrame: 6 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
timeFrame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
timeFrame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
timeFrame: 2 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
timeFrame: 6 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
timeFrame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
timeFrame: 10 weeks
measure: Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
timeFrame: 10 weeks
measure: Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
timeFrame: 2 weeks
measure: Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
timeFrame: 2 weeks
measure: Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
timeFrame: 2 weeks
measure: Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
timeFrame: 2 weeks
measure: Safety of ADC3680 compared to placebo
timeFrame: 10 weeks
measure: Safety of a 2 week administration of ADC3680 in combination with montelukast
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pulmagen Investigational Site
state: Alabama
city: Huntington Beach
country: United States
facility: Pulmagen Investigational Site
state: California
city: Riverside
country: United States
facility: Pulmagen Investigational Site
state: California
city: Rolling Hills
country: United States
facility: Pulmagen Investigational Site
state: California
city: San Jose
country: United States
facility: Pulmagen Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pulmagen Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Pulmagen Investigational Site
state: Connecticut
city: Lawrenceville
country: United States
facility: Pulmagen Investigational Site
state: Georgia
city: Eagle
country: United States
facility: Pulmagen Investigational Site
state: Idaho
city: Nottingham
country: United States
facility: Pulmagen Investigational Site
state: Maryland
city: Plymouth
country: United States
facility: Pulmagen Investigational Site
state: Minnesota
city: Bellevue
country: United States
facility: Pulmagen Investigational Site
state: Nebraska
city: Bricktown
country: United States
facility: Pulmagen Investigational Site
state: New Jersey
city: Clemmons
country: United States
facility: Pulmagen Investigatinal Site
state: North Carolina
city: Canton
country: United States
facility: Pulmagen Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pulamgen Investigational Site
state: Ohio
city: Maumee
country: United States
facility: Pulmagen Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pulmagen Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pulmagen Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Pulmagen Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pulmagen Investigational Site
state: Oregon
city: East Providence
country: United States
facility: Pulmagen Investigational Site
state: Rhode Island
city: Warwick
country: United States
facility: Pulmagen Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pulmagen Investigational Site
state: South Carolina
city: Fort Mill
country: United States
facility: Pulmagen Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: Pulmagen Investigational Site
state: Texas
city: Austin
country: United States
facility: Pulmagen Investigational Site
state: Texas
city: Houston
country: United States
facility: Pulmagen Investigational Site
state: Texas
city: Killeen
country: United States
facility: Pulmagen Investigational Site
state: Texas
city: Waco
country: United States
facility: Pulmagen Investigational Site
state: Texas
city: Woodway
country: United States
facility: Pulmagen Investgational Site
state: Texas
city: Draper
country: United States
facility: Pulmagen Investigational Site
state: Utah
city: Seattle
country: United States
facility: Pulmagen Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pulmagen Investigational Site
state: Washington
city: Greenfield
country: United States
facility: Pulmagen Investigational Site
state: Wisconsin
city: Cakovec
country: Croatia
facility: Pulmagen Investigational Site
city: Sisak
country: Croatia
facility: Pulmagen Investigational Site
city: Varazdin
country: Croatia
facility: Pulmagen Investigational Site
city: Zagreb
country: Croatia
facility: Pulmagen Investigational Site
city: Beroun
country: Czechia
facility: Pulmagen Investigational Site
city: Brno
country: Czechia
facility: Pulmagen Investigational Site
city: Havlickuv Brod
country: Czechia
facility: Pulmagen Investigational Site
city: Holesov
country: Czechia
facility: Pulmagen Investigational Site
city: Jaromer
country: Czechia
facility: Pulmagen Investigational Site
city: Neratovice
country: Czechia
facility: Pulmagen Investigational Site
city: Svitavy
country: Czechia
facility: Pulmagen Investigational Site
city: Teplice
country: Czechia
facility: Pulmagen Investigational Site
city: Tremosna
country: Czechia
facility: Pulmagen Investigational Site
city: Augsburg
country: Germany
facility: Pulmagen Investigational Site
city: Bad Worishofen
country: Germany
facility: Pulmagen Investigational Site
city: Berlin
country: Germany
facility: Pulmagen Investigational Site
city: Bonn
country: Germany
facility: Pulmagen Investigational Site
city: Deggingen
country: Germany
facility: Pulmagen Investigational Site
city: Dresden
country: Germany
facility: Pulmagen Investigational Site
city: Geesthacht
country: Germany
facility: Pulmagen Investigational Site
city: Hagen
country: Germany
facility: Pulmagen Investigational Site
city: Hamburg
country: Germany
facility: Pulmagen Investigational Site
city: Hannover
country: Germany
facility: Pulmagen Investigational Site
city: Marburg
country: Germany
facility: Pulmagen Investigational Site
city: Schwerin
country: Germany
facility: Pulmagen Investigational Site
city: Teuchem
country: Germany
facility: Pulmagen Investigational Site
city: Weyhe
country: Germany
facility: Pulmagen Investigational Site
city: Balassagyarmat
country: Hungary
facility: Pulmagen Investigational Site
city: Budapest
country: Hungary
facility: Pulmagen Investigational Site
city: Kaposvar
country: Hungary
facility: Pulmagen Investigational Site
city: Komlo
country: Hungary
facility: Pulmagen Investigational Site
city: Pecs
country: Hungary
facility: Pulmagen Investigational Site
city: Szazhalombatta
country: Hungary
facility: Pulmagen Investigational Site
city: Szombathely
country: Hungary
facility: Pulmagen Investigational Site
city: Bialystok
country: Poland
facility: Pulmagen Investigational Site
city: Bielsko Biala
country: Poland
facility: Pulmagen Investigational Site
city: Bienkowka
country: Poland
facility: Pulmagen Investigational Site
city: Bydgoszcz
country: Poland
facility: Pulmagen Investigational Site
city: Kielce
country: Poland
facility: Pulmagen Investigational Site
city: Krakow
country: Poland
facility: Pulmagen Investigational Site
city: Lodz
country: Poland
facility: Pulmagen Investigational Site
city: Olsztyn
country: Poland
facility: Pulmagen Investigational Site
city: Ostrow Wilekopolski
country: Poland
facility: Pulmagen Investigational Site
city: Poznan
country: Poland
facility: Pulmagen Investigational Site
city: Proszowice
country: Poland
facility: Pulmagen Investigational Site
city: Skierniewice
country: Poland
facility: Pulmagen Investigational Site
city: Tarnow
country: Poland
facility: Pulmagen Investigational Site
city: Warszawa
country: Poland
facility: Pulamgen Investigational Site
city: Wilkowice-Bystra
country: Poland
facility: Pulmagen Investigational Site
city: Wroclaw
country: Poland
facility: Pulmagen Investigational Site
city: Zabrze
country: Poland
facility: Pulmagen Investigational Site
city: Zgierz
country: Poland
facility: Pulmagen Investigational Site
Study officials:
References: