Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 763
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms:
arm 1: Ensifentrine Nebulized Suspension; 3 mg BID arm 2: Placebo Nebulized BID

Interventions: intervention 1: Ensifentrine intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks intervention 2: Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks

Protocol document:
Prot_000.pdf: 













































































































































































































































































SAP_001.pdf: 






























































































































































































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