Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Phase 3

Completed

• Conditions: Low Peak Inspiratory Flow Rate (PIFR); Chronic Obstructive Pulmonary Disease, COPD
• Interventions: Combination Product: Spiriva Handihaler®; Drug: Revefenacin; Drug: Placebo for Spiriva Handihaler®; Drug: Placebo for Revefenacin

• Registration Number: NCT03095456
• Lead Sponsor: Mylan Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-24
• Study Start: 2017-03-27
• Study First Posted: 2017-03-29
• Primary Completion: 2017-11-25
• Study Completion: 2017-11-25
• Disposition First Submitted: 2018-09-20
• Disposition First Submitted QC: 2018-09-20
• Disposition First Posted: 2018-09-25
• Results First Submitted: 2018-12-06
• Results First Submitted QC: 2018-12-06
• Results First Posted: 2018-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Subject is a male or female subject 40 years of age or older with a diagnosis of COPD.
• Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
• Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.

Exclusion Criteria

• Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug.
• Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics.
• Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revefenacin	Placebo for Spiriva Handihaler®	Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Spiriva Handihaler®	Placebo for Revefenacin	Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Spiriva Handihaler®	Spiriva Handihaler®	Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Revefenacin	Revefenacin	Active Revefenacin and placebo (in place of Spiriva Handihaler®)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough FEV1 on Day 29	Baseline and Day 29	FEV1 = forced expiratory volume at one second

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Trough Inspiratory Capacity (IC) on Day 29	Baseline and Day 29
Change From Baseline Peak FEV1 on Day 29	Baseline and Day 29 (0-4 hours)
Change From Baseline Peak FVC on Day 29	Baseline and Day 29 (0-4 hours)
Summary of Rescue Medication Use: Puffs Per Day	1 Month
Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29	Baseline and Day 29

Trial Locations

Locations (1)

Clinical Research of Rock Hill; 🇺🇸 Rock Hill, South Carolina, United States