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OpenTrials
Completed

NCT Number: NCT03095456

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease, COPD Chronic Disease Disease Attributes Low Peak Inspiratory Flow Rate (PIFR) Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revefenacin

Drug

Revefenacin administered via nebulization.

Other names: TD-4208

Spiriva Handihaler®

Combination Product

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

Other names: Tiotropium

Placebo for Revefenacin

Drug

Placebo administered as double blind, double dummy via nebulization.

Placebo for Spiriva Handihaler®

Drug

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

Primary outcomes

  1. Change From Baseline in Trough FEV1 on Day 29

    Time frame: Baseline and Day 29

    FEV1 = forced expiratory volume at one second

Secondary outcomes

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

    Time frame: Baseline and Day 29

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

    Time frame: Baseline and Day 29

  3. Change From Baseline Peak FEV1 on Day 29

    Time frame: Baseline and Day 29 (0-4 hours)

  4. Change From Baseline Peak FVC on Day 29

    Time frame: Baseline and Day 29 (0-4 hours)

  5. Summary of Rescue Medication Use: Puffs Per Day

    Time frame: 1 Month

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2017
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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