A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Trial Parameters
Brief Summary
This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
Eligibility Criteria
Inclusion Criteria: * Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study and for at least 30 days post-study * Females are eligible to participate if they are not pregnant, breastfeeding and if one of the following conditions apply: 1. Not a woman of child-bearing potential OR 2. Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study 3. Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study * Current of former cigarette smokers with a history of smoking ≥ 10 pack years at the time of signing informed consent \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smoker