Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Chronic Obstructive Pulmonary Disease, COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095456
• Other study ID #: 0149
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2017
• Est. completion date: November 25, 2017

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: November 25, 2017
• Est. primary completion date: November 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease, COPD
• Low Peak Inspiratory Flow Rate (PIFR)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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.
• Placebo for Spiriva Handihaler®
Placebo administered as double blind, double dummy via Spiriva HandiHaler®.

Locations

Country	Name	City	State
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough FEV1 on Day 29	FEV1 = forced expiratory volume at one second	Baseline and Day 29
Secondary	Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29		Baseline and Day 29
Secondary	Change From Baseline Trough Inspiratory Capacity (IC) on Day 29		Baseline and Day 29
Secondary	Change From Baseline Peak FEV1 on Day 29		Baseline and Day 29 (0-4 hours)
Secondary	Change From Baseline Peak FVC on Day 29		Baseline and Day 29 (0-4 hours)
Secondary	Summary of Rescue Medication Use: Puffs Per Day		1 Month