Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

NCT03095456 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 0149
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough FEV1 on Day 29

  FEV1 = forced expiratory volume at one second

  Baseline and Day 29

Secondary Outcomes (5)

• 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

Study Arms (2)

Revefenacin

EXPERIMENTAL

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

Drug: Revefenacin; Drug: Placebo for Spiriva Handihaler®

Spiriva Handihaler®

ACTIVE COMPARATOR

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

Combination Product: Spiriva Handihaler®; Drug: Placebo for Revefenacin

Interventions

Revefenacin DRUG

Revefenacin administered via nebulization.

Also known as: TD-4208

Revefenacin

Spiriva Handihaler® COMBINATION_PRODUCT

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

Also known as: Tiotropium

Spiriva Handihaler®

Placebo for Revefenacin DRUG

Placebo administered as double blind, double dummy via nebulization.

Spiriva Handihaler®

Placebo for Spiriva Handihaler® DRUG

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

Revefenacin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Inc.: lead
• Theravance Biopharma: collaborator

Study Sites (1)

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Related Publications (3)

• Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024.

  PMID: 38560416 DERIVED

• 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.

  PMID: 32343967 DERIVED

• 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.

  PMID: 31647854 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

revefenacin; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Head of Clinical Development & Medical Affairs
• Organization: Theravance Biopharma

medinfo@theravance.com

1-855-633-8479

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 29, 2017
• Study Start: March 27, 2017
• Primary Completion: November 25, 2017
• Study Completion: November 25, 2017
• Last Updated: February 24, 2022
• Results First Posted: December 31, 2018

Record last verified: 2022-02

Locations

US (1)