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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
248
ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
montelukast for 12 weeks
Efficacy of ADC3680 compared with placebo in improving lung function (FEV1)
Time frame: 10 weeks
Adding montelukast to ADC3680 in improving lung function (FEV1)
Time frame: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in Asthma Control Questionnaire (ACQ) from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 2
Time frame: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 6
Time frame: 6 weeks
Efficacy of ADC3680 compared with placebo on mean change in trough pre-bronchodilator FEV1 % predicted from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in post-bronchodilator FEV1 from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 2
Time frame: 2 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 6
Time frame: 6 weeks
Efficacy of ADC3680 compared with placebo on mean change in pre-bronchodilator PEF (in-clinic) from baseline to Week 10
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Pulmagen Investigational Site
Birmingham, Alabama, United States
Pulmagen Investigational Site
Huntington Beach, California, United States
Pulmagen Investigational Site
Riverside, California, United States
Pulmagen Investigational Site
Rolling Hills, California, United States
Pulmagen Investigational Site
San Jose, California, United States
Pulmagen Investigational Site
Colorado Springs, Colorado, United States
Pulmagen Investigational Site
Waterbury, Connecticut, United States
Pulmagen Investigational Site
Lawrenceville, Georgia, United States
Pulmagen Investigational Site
Eagle, Idaho, United States
Pulmagen Investigational Site
Nottingham, Maryland, United States
...and 77 more locations
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in blood eosinophils from baseline to Week 10
Time frame: 10 weeks
Efficacy of ADC3680 compared with placebo on mean change in serum IgE from baseline to Week 10
Time frame: 10 weeks
Adding montelukast to ADC3680 on mean change in ACQ scores from Week 10 to Week 12
Time frame: 2 weeks
Adding montelukast to ADC3680 on mean change in trough pre-bronchodilator FEV1 % predicted from Week 10 to Week 12
Time frame: 2 weeks
Adding montelukast to ADC3680 on mean change in pre-bronchodilator PEF (in-clinic) from Week 10 to Week 12
Time frame: 2 weeks
Adding montelukast to ADC3680 on mean change in blood eosinophils from Week 10 to Week 12
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks