NCT03095456

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

A Phase 3b, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study to Compare Once Daily Nebulized Revefenacin With Spiriva Once Daily Delivered Via the HandiHaler® on Lung Function in Subjects With COPD and a Low PIFR

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.

Conditions

• Chronic Obstructive Pulmonary Disease, COPD
• Low Peak Inspiratory Flow Rate (PIFR)

Interventions

Type	Name	Description
DRUG	Revefenacin	Revefenacin administered via nebulization.
COMBINATION_PRODUCT	Spiriva Handihaler®	Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
DRUG	Placebo for Revefenacin	Placebo administered as double blind, double dummy via nebulization.
DRUG	Placebo for Spiriva Handihaler®	Placebo administered as double blind, double dummy via Spiriva HandiHaler®.

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-11-25
• Completion: 2017-11-25
• First posted: 2017-03-29
• Last updated: 2022-02-24
• Results posted: 2018-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study