At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, 42-day, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized Revefenacin and Nebulized Formoterol Fumarate (PERFOROMIST®) Administered in Sequence and as a Combined Solution in Subjects With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Revefenacin, Placebo, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 122 participants across 12 sites.
Detailed Summary
The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.
Study Details
Timeline
Interventions
Revefenacin is administered via a nebulizer.
Placebo version of Revefenacin is administered via a nebulizer.
Administered sequentially in both revefenacin and placebo arms using a nebulizer.