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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01730027

Run by

Pulmagen Therapeutics

People needed

248

Starts

2013-04-01

Expected to finish

2014-12-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Pulmagen Investigational Site — Plymouth, Minnesota, United States
• Pulmagen Investigational Site — Bellevue, Nebraska, United States
• Pulmagen Investigational Site — Brick, New Jersey, United States
• Pulmagen Investigatinal Site — Clemmons, North Carolina, United States
• Pulmagen Investigational Site — Canton, Ohio, United States
• Pulamgen Investigational Site — Cincinnati, Ohio, United States
• Pulmagen Investigational Site — Maumee, Ohio, United States
• Pulmagen Investigational Site — Oklahoma City, Oklahoma, United States
• Pulmagen Investigational Site — Tulsa, Oklahoma, 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, United States
• Pulmagen Investigational Site — Charleston, South Carolina, United States
• Pulmagen Investigational Site — Fort Mill, South Carolina, United States
• Pulmagen Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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