At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 763 enrolled
Drug / intervention
Ensifentrine +1 moredrug
Likely dose
Ensifentrine 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA·interventional·Posted Sep 2, 2020·Updated Nov 13, 2023
In Brief
A Phase 3 clinical trial evaluating Ensifentrine and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 763 participants across 122 sites in 12 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBulgaria, Czechia, Germany, Greece, Hungary, Poland, Romania, Russia, Slovakia, South Korea, United Kingdom, United States
CollaboratorsIQVIA Pty Ltd
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartSep 2020
Primary CompletionSep 2022
Study CompletionDec 2022
TodayJul 2026
First PostedSep 2, 2020
Enrollment StartSep 29, 2020
Primary CompletionSep 12, 2022
Study CompletionDec 2, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.8 years ago
Interventions
Ensifentrinedrug
Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks
Placebodrug
Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks