NCT03573817

A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Revefenacin	Revefenacin is administered via a nebulizer.
DRUG	Placebo	Placebo version of Revefenacin is administered via a nebulizer.
DRUG	Formoterol	Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Timeline

• Start date: 2018-05-31
• Primary completion: 2018-09-25
• Completion: 2018-09-25
• First posted: 2018-06-29
• Last updated: 2022-02-24
• Results posted: 2019-12-18

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study