A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pulmagen Therapeutics
• Treatments: Montelukast

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.