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Trial record 1 of 1 for:    NCT05165485
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Phase 4 COPD and Suboptimal Inspiratory Flow Rate (PIFR-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05165485
Recruitment Status : Recruiting
First Posted : December 21, 2021
Last Update Posted : May 5, 2022
Sponsor:
Collaborator:
Mylan Inc.
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Revefenacin Drug: Tiotropium Drug: Revefenacin Placebo Drug: Tiotropium Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)
Actual Study Start Date : January 7, 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Revefenacin
Revefenacin DoseA administered with tiotropium placebo
Drug: Revefenacin
Revefenacin DoseA
Other Name: Yupelri

Drug: Tiotropium Placebo
Placebo for Tiotropium administered with Revefenacin

Active Comparator: Tiotropium
Tiotropium DoseB administered with revefenacin placebo
Drug: Tiotropium
Tiotropium DoseB

Drug: Revefenacin Placebo
Placebo for Revefenacin administered with Tiotropium




Primary Outcome Measures :
  1. FEV1 [ Time Frame: Day 85 following 84 days of dosing ]
    Change from baseline in trough FEV1


Secondary Outcome Measures :
  1. OTE on FEV1 [ Time Frame: Baseline through Day 85 ]
    Trough Overall treatment effect (OTE) on FEV1

  2. 80-mL improvement in trough FEV1 [ Time Frame: Day 85 ]
    Percentage of participants who achieve at least an 80-mL improvement in trough FEV1

  3. FVC [ Time Frame: Day 85 ]
    Change from baseline in Trough FVC

  4. Average Daily Rescue Albuterol MDI usage [ Time Frame: Baseline through Day 85 ]
    Average Daily Rescue Albuterol MDI usage based on the average number of puffs per day over the treatment period



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:

  1. Participant is a male or female 40 years of age or older.
  2. Participant is female and is nonpregnant and nonlactating. A woman of childbearing potential must have a documented negative urine pregnancy test at screening. Women are considered not to be of childbearing potential if they have had a total hysterectomy and/or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal.
  3. During the study and for 30 days after receiving the last dose of study drug, women of childbearing potential and men capable of fathering children must agree to use highly effective birth control measures or agree to abstain from sexual intercourse.

    A highly effective method of birth control is defined as one that results in a low failure rate (i.e. <1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD] with documented failure rate of <1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with an additional barrier method.

  4. Participant has a diagnosis of COPD, specifically, a post-ipratropium FEV1/FVC ratio <0.7.
  5. Participant has a postipratropium FEV1 < 50% of predicted normal (using National Health and Nutrition Examination Survey-predicted equations) and absolute FEV1 > 700 mL.
  6. Participant has a PIFR <60 L/min as measured by an In-Check™ device with resistance set to DISKUS at Visit 1A (if not combined with Visit 1B) and < 55 L/min as measured by an In-Check™ device with resistance set to DISKUS at Visit 1B and Visit 2 prior to randomization.
  7. Participant is capable of performing reproducible spirometry maneuvers (and plethysmography maneuvers for a subset of participants) as described by current American Thoracic Society (ATS) Guidelines.
  8. Participant is an active or former smoker with a cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
  9. Participant or legal guardian is willing and able to provide signed and dated informed consent to participate prior to initiation of any study related procedures.
  10. Participant is willing and able to adhere to all study assessments/procedures. Care partner assistance is acceptable.
  11. Participant is willing and able to adhere to all restrictions during their study participation as follows:

    • Use of recreational drugs
    • Medicinal marijuana
    • Excessive alcohol during the study period
    • Participation in another investigational drug study
    • Donation of ≥500 mL blood (or equivalent)
  12. Participant (or care partner) based on the investigator's assessment is able to properly prepare and administer study medication administered from both nebulizer and HandiHaler® according to their respective Instructions for Use.

Exclusion Criteria:

  1. Participant has a concurrent disease or condition that, in the opinion of the investigator, would interfere with study participation or confound the evaluation of safety and tolerability of the study drug.
  2. Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics.
  3. Participant 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.
  4. Participant has Moderate to Severe Hepatic impairment (Child-Pugh B or C) or Severe Renal Insufficiency (i.e. a glomerular filtration rate <30 mL/min/1.72m2).
  5. Participant has been hospitalized for COPD or pneumonia within 8 weeks prior to Visit 1.
  6. Participant is receiving a LABA or LABA/inhaled corticosteroid (ICS; either QD or BID) at a dose that has been stable for ≤ 30 days prior to screening.
  7. Participant has used systemic corticosteroids within 8 weeks of Visit 1.
  8. Participant has used antibiotics for respiratory tract infections within 8 weeks of Visit 1, or is using antibiotics prophylactically.
  9. Participant received COVID-19 vaccine within 2 weeks prior to Visit 1.

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): NCT05165485


Contacts
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Contact: Medical Monitor 1-855-633-8479 medinfo@theravance.com

Locations
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United States, Alabama
Theravance Biopharma Investigational Site Recruiting
Jasper, Alabama, United States, 35501
United States, Arizona
Theravance Biopharma Recruiting
Phoenix, Arizona, United States, 85018
United States, Florida
Theravance Biopharma Investigational Site Recruiting
Clearwater, Florida, United States, 33756
Theravance Biopharma Investigational Site Recruiting
Clearwater, Florida, United States, 33765
Theravance Biopharma Investigational Site Recruiting
Leesburg, Florida, United States, 34748
Theravance Biopharma Investigational Site Recruiting
Miami, Florida, United States, 33155
Theravance Biopharma Investigational Site Recruiting
Miami, Florida, United States, 33186
Theravance Biopharma Investigational Site Recruiting
Orlando, Florida, United States, 32825
Theravance Biopharma Investigational Site Recruiting
Ormond Beach, Florida, United States, 32174
Theravance Biopharma Investigational Site Recruiting
Sarasota, Florida, United States, 34239
Theravance Biopharma Investigational Site Recruiting
Tampa, Florida, United States, 33606
Theravance Biopharma Investigational Site Recruiting
Winter Park, Florida, United States, 32789
United States, Indiana
Theravance Biopharma Investigational Site Recruiting
Valparaiso, Indiana, United States, 46383
United States, Massachusetts
Theravance Biopharma Investigational Site Recruiting
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Theravance Biopharma Investigational Site Recruiting
Farmington Hills, Michigan, United States, 48336
United States, Missouri
Theravance Biopharma Investigational Site Recruiting
Saint Charles, Missouri, United States, 63301
United States, Nevada
Theravance Biopharma Investigational Site Recruiting
Las Vegas, Nevada, United States, 89106
United States, North Carolina
Theravance Biopharma Investigational Site Recruiting
Charlotte, North Carolina, United States, 28207
Theravance Biopharma Investigational Site Recruiting
Monroe, North Carolina, United States, 28112
Theravance Biopharma Investigational Site Recruiting
Raleigh, North Carolina, United States, 27607
United States, Ohio
Theravance Biopharma Investigational Site Recruiting
Cincinnati, Ohio, United States, 45242
Theravance Biopharma Investigational Site Recruiting
Columbus, Ohio, United States, 43215
United States, Oregon
Theravance Biopharma Investigational Site Not yet recruiting
Grants Pass, Oregon, United States, 97527
Theravance Biopharma Investigational Site Recruiting
Medford, Oregon, United States, 97504
Theravance Biopharma Investigational Site Recruiting
Portland, Oregon, United States, 97202
United States, South Carolina
Theravance Biopharma Investigational Site Recruiting
Anderson, South Carolina, United States, 29621
Theravance Biopharma Investigational Site Recruiting
Columbia, South Carolina, United States, 29204
Theravance Biopharma Investigational Site Recruiting
Gaffney, South Carolina, United States, 29340
Theravance Biopharma Investigational Site Recruiting
Greenville, South Carolina, United States, 29615
Theravance Biopharma Investigational Site Recruiting
Lexington, South Carolina, United States, 29072
Theravance Biopharma Investigational Site Recruiting
North Charleston, South Carolina, United States, 29406
Theravance Biopharma Investigational Site Recruiting
Rock Hill, South Carolina, United States, 29732
Theravance Biopharma Investigational Site #2 Recruiting
Spartanburg, South Carolina, United States, 29303
Theravance Biopharma Investigational Site Recruiting
Spartanburg, South Carolina, United States, 29303
Theravance Biopharma Investigational Site Recruiting
Union, South Carolina, United States, 29379
United States, Tennessee
Theravance Biopharma Investigational Site Recruiting
Franklin, Tennessee, United States, 37067
Theravance Biopharma Investigational Site Recruiting
Knoxville, Tennessee, United States, 37909
United States, Texas
Theravance Biopharma Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Theravance Biopharma Investigational Site Recruiting
Sherman, Texas, United States, 75092
Sponsors and Collaborators
Theravance Biopharma
Mylan Inc.
Investigators
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Study Director: Medical Monitor Theravance Biopharma
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT05165485    
Other Study ID Numbers: 0180
First Posted: December 21, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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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 Theravance Biopharma:
COPD
Peak Inspiratory Flow Rate
PIFR
Pulmonary Function
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