Trial record 1 of 1 for:
NCT05165485
Phase 4 COPD and Suboptimal Inspiratory Flow Rate (PIFR-2)
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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 |
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Recruitment Status :
Recruiting
First Posted : December 21, 2021
Last Update Posted : May 5, 2022
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Sponsor:
Theravance Biopharma
Collaborator:
Mylan Inc.
Information provided by (Responsible Party):
Theravance Biopharma
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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 |
| 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 |
|---|---|
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Experimental: Revefenacin
Revefenacin DoseA administered with tiotropium placebo
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Drug: Revefenacin
Revefenacin DoseA
Other Name: Yupelri Drug: Tiotropium Placebo Placebo for Tiotropium administered with Revefenacin |
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Active Comparator: Tiotropium
Tiotropium DoseB administered with revefenacin placebo
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Drug: Tiotropium
Tiotropium DoseB Drug: Revefenacin Placebo Placebo for Revefenacin administered with Tiotropium |
Primary Outcome Measures :
- FEV1 [ Time Frame: Day 85 following 84 days of dosing ]Change from baseline in trough FEV1
Secondary Outcome Measures :
- OTE on FEV1 [ Time Frame: Baseline through Day 85 ]Trough Overall treatment effect (OTE) on FEV1
- 80-mL improvement in trough FEV1 [ Time Frame: Day 85 ]Percentage of participants who achieve at least an 80-mL improvement in trough FEV1
- FVC [ Time Frame: Day 85 ]Change from baseline in Trough FVC
- 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:
- Participant is a male or female 40 years of age or older.
- 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.
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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.
- Participant has a diagnosis of COPD, specifically, a post-ipratropium FEV1/FVC ratio <0.7.
- Participant has a postipratropium FEV1 < 50% of predicted normal (using National Health and Nutrition Examination Survey-predicted equations) and absolute FEV1 > 700 mL.
- 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.
- 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.
- 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.
- 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.
- Participant is willing and able to adhere to all study assessments/procedures. Care partner assistance is acceptable.
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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)
- 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:
- 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.
- Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics.
- 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.
- 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).
- Participant has been hospitalized for COPD or pneumonia within 8 weeks prior to Visit 1.
- 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.
- Participant has used systemic corticosteroids within 8 weeks of Visit 1.
- Participant has used antibiotics for respiratory tract infections within 8 weeks of Visit 1, or is using antibiotics prophylactically.
- 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
| Contact: Medical Monitor | 1-855-633-8479 | medinfo@theravance.com |
Locations
| 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
| Study Director: | Medical Monitor | Theravance Biopharma |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Theravance Biopharma:
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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 |