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Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Revefenacin

Spiriva Handihaler®

Placebo for Revefenacin

Placebo for Spiriva Handihaler®

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease, COPD focused on measuring Chronic Obstructive Pulmonary Disease, COPD, Low Peak Inspiratory Flow Rate (PIFR)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Research of Rock Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Revefenacin

Spiriva Handihaler®

Arm Description

Active Revefenacin and placebo (in place of Spiriva Handihaler®)

Active Spiriva Handihaler® and placebo (in place of Revefenacin)

Outcomes

Primary Outcome Measures

Change From Baseline in Trough FEV1 on Day 29

FEV1 = forced expiratory volume at one second

Secondary Outcome Measures

Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29

Change From Baseline Trough Inspiratory Capacity (IC) on Day 29

Change From Baseline Peak FEV1 on Day 29

Change From Baseline Peak FVC on Day 29

Summary of Rescue Medication Use: Puffs Per Day

Full Information

NCT ID

NCT03095456

First Posted

March 24, 2017

Last Updated

February 22, 2022

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT03095456

Brief Title

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

March 27, 2017 (Actual)

Primary Completion Date

November 25, 2017 (Actual)

Study Completion Date

November 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Revefenacin

Arm Type

Experimental

Arm Description

Active Revefenacin and placebo (in place of Spiriva Handihaler®)

Arm Title

Spiriva Handihaler®

Arm Type

Active Comparator

Arm Description

Active Spiriva Handihaler® and placebo (in place of Revefenacin)

Intervention Type

Drug

Intervention Name(s)

Revefenacin

Other Intervention Name(s)

TD-4208

Intervention Description

Revefenacin administered via nebulization.

Intervention Type

Combination Product

Intervention Name(s)

Spiriva Handihaler®

Other Intervention Name(s)

Tiotropium

Intervention Description

Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.

Intervention Type

Drug

Intervention Name(s)

Placebo for Revefenacin

Intervention Description

Placebo administered as double blind, double dummy via nebulization.

Intervention Type

Drug

Intervention Name(s)

Placebo for Spiriva Handihaler®

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Trough FEV1 on Day 29

Description

FEV1 = forced expiratory volume at one second

Time Frame

Baseline and Day 29

Secondary Outcome Measure Information:

Title

Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29

Time Frame

Baseline and Day 29

Title

Change From Baseline Trough Inspiratory Capacity (IC) on Day 29

Time Frame

Baseline and Day 29

Title

Change From Baseline Peak FEV1 on Day 29

Time Frame

Baseline and Day 29 (0-4 hours)

Title

Change From Baseline Peak FVC on Day 29

Time Frame

Baseline and Day 29 (0-4 hours)

Title

Summary of Rescue Medication Use: Puffs Per Day

Time Frame

1 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research of Rock Hill

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32343967

Citation

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.

Results Reference

derived

PubMed Identifier

31647854

Citation

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.

Results Reference

derived

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Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

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