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).
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
Not a woman of child-bearing potential OR
Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study
Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease
Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization
Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular glucocorticoids, antibiotics, theophylline, and roflumilast)
History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation
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Treatment groupsSee each treatment group below.