This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer up to 52 weeks, compared to placebo, in participants with non-cystic fibrosis bronchiectasis (NCFBE).
Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance from Screening throughout the study and for at least 30 days after the last dose of blinded study medication
Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by chest CT demonstrating bronchiectasis affecting 1 or more lobes. Confirmation may be based on prior chest CT within the prior 5 years; subjects whose past CT image records are not available will require chest CT scan during screening Notes: If a subject has no clinical history consistent with bronchiectasis, they may not be re-screened
A diagnosis of COPD or a primary diagnosis of asthma, as judged by the investigator
Bronchiectasis due to cystic fibrosis, primary hypogammaglobulinemia common variable immunodeficiency, severe immunodeficiency, or requirement for treatment with intravenous immunoglobulin
Current smoker defined as by the Centers for Disease Control and Prevention (CDC)
Meets both of the following
Parallel
Nebulized Ensifentrine Suspension; 3 mg
DrugAdministered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks
Nebulized Placebo Solution
DrugAdministered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks
Rate of protocol-defined pulmonary exacerbations (number of events per subject-year)
Time to the onset of the first protocol-defined pulmonary exacerbation
Change from Baseline in Evaluating Respiratory Symptoms (E-RS) Cough and Sputum Domain score
The E-RS is a patient reported outcome that is derived from the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT)-PRO in the participants e-diary, to quantify the severity of symptoms. The score ranges from 0 to 40 with a higher score representing more severe symptoms.
Change from Baseline in Saint George's Respiratory Questionnaire (SGRQ) total score
SGRQ scores range from 0 to 100, with a higher score representing worse health.
Change from Baseline in quality of life - bronchiectasis questionnaire (QOL-B) Respiratory Symptoms Domain score
The QOL-B Respiratory Symptoms Domain score ranges from 0 to 100, with higher scores representing better functioning.
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