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Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

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ClinicalTrials.gov Identifier: NCT03095456
Recruitment Status : Completed
First Posted : March 29, 2017
Results First Posted : December 31, 2018
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Mylan Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease, COPD Low Peak Inspiratory Flow Rate (PIFR) Drug: Revefenacin Combination Product: Spiriva Handihaler® Drug: Placebo for Revefenacin Drug: Placebo for Spiriva Handihaler® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : November 25, 2017
Actual Study Completion Date : November 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Revefenacin
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Drug: Revefenacin
Revefenacin administered via nebulization.
Other Name: 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 Name: Tiotropium

Drug: Placebo for Revefenacin
Placebo administered as double blind, double dummy via nebulization.




Primary Outcome Measures :
  1. Change From Baseline in Trough FEV1 on Day 29 [ Time Frame: Baseline and Day 29 ]
    FEV1 = forced expiratory volume at one second


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095456


Locations
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United States, South Carolina
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States, 29732
Sponsors and Collaborators
Mylan Inc.
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
  Study Documents (Full-Text)

Documents provided by Mylan Inc.:
Study Protocol  [PDF] April 4, 2017
Statistical Analysis Plan  [PDF] November 27, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT03095456    
Other Study ID Numbers: 0149
First Posted: March 29, 2017    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: May 7, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mylan Inc.:
Chronic Obstructive Pulmonary Disease, COPD
Low Peak Inspiratory Flow Rate (PIFR)
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action