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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)
• Intervention / Treatment: Drug: Revefenacin; Drug: Placebo for Spiriva Handihaler®; Combination product: Spiriva Handihaler®; Drug: Placebo for Revefenacin

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revefenacin; Active Revefenacin and placebo (in place of Spiriva Handihaler®)	Drug: Revefenacin; Revefenacin administered via nebulization.; Other Names: TD-4208; Drug: Placebo for Spiriva Handihaler®; Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
Active Comparator: Spiriva Handihaler®; Active Spiriva Handihaler® and placebo (in place of Revefenacin)	Combination product: Spiriva Handihaler®; Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.; Other Names: Tiotropium; Drug: Placebo for Revefenacin; Placebo administered as double blind, double dummy via nebulization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough FEV1 on Day 29	FEV1 = forced expiratory volume at one second	Baseline and Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29	Baseline and Day 29
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

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: Theravance Biopharma

Publications and helpful links

General Publications

• Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.
• Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):321-31. doi: 10.15326/jcopdf.6.4.2019.0137.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): November 25, 2017
• Study Completion (Actual): November 25, 2017

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 0149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No