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Phase 4 COPD and Suboptimal Inspiratory Flow Rate

NCT ID: NCT05165485

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2023-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Peak Inspiratory Flow Rate PIFR Pulmonary Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Revefenacin

Revefenacin administered with Tiotropium Placebo

Group Type EXPERIMENTAL

Revefenacin

Intervention Type DRUG

Revefenacin 175 mcg administered once daily for 84 days via nebulization

Tiotropium Placebo

Intervention Type DRUG

Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®

Tiotropium

Tiotropium administered with Revefenacin Placebo

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Tiotropium 18 mcg administered once daily for 84 days via Spiriva HandiHaler®

Revefenacin Placebo

Intervention Type DRUG

Placebo for Revefenacin administered once daily for 84 days via nebulization

Interventions

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Revefenacin

Revefenacin 175 mcg administered once daily for 84 days via nebulization

Intervention Type DRUG

Tiotropium

Tiotropium 18 mcg administered once daily for 84 days via Spiriva HandiHaler®

Intervention Type DRUG

Revefenacin Placebo

Placebo for Revefenacin administered once daily for 84 days via nebulization

Intervention Type DRUG

Tiotropium Placebo

Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®

Intervention Type DRUG

Other Intervention Names

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Yupelri® TD-4208 Spiriva®

Eligibility Criteria

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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 post ipratropium 30% ≤ FEV1 \< 50% of predicted normal (using National Health and Nutrition Examination Survey-predicted equations) and absolute FEV1 \> 500 mL, or FEV1 \<30% predicted normal 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/1.72m\^2).
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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viatris Inc.

INDUSTRY

Sponsor Role collaborator

Theravance Biopharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

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Theravance Biopharma Investigational Site

Jasper, Alabama, United States

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Theravance Biopharma Investigational Site

Phoenix, Arizona, United States

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Theravance Biopharma Investigational Site

Tucson, Arizona, United States

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Theravance Biopharma Investigational Site

Newport Beach, California, United States

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Theravance Biopharma Investigational Site

San Diego, California, United States

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Theravance Biopharma Investigational Site

Stockton, California, United States

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Theravance Biopharma Investigational Site

Upland, California, United States

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Theravance Biopharma Investigational Site

Lakewood, Colorado, United States

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Theravance Biopharma Investigational Site

Brandon, Florida, United States

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Theravance Biopharma Investigational Site

Clearwater, Florida, United States

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Theravance Biopharma Investigational Site site 2

Clearwater, Florida, United States

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Theravance Biopharma Investigational Site

Clearwater, Florida, United States

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Theravance Biopharma Investigational Site

Daytona Beach, Florida, United States

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Theravance Biopharma Investigational Site

Leesburg, Florida, United States

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Theravance Biopharma Investigational Site

Miami, Florida, United States

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Theravance Biopharma Investigational Site

Miami, Florida, United States

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Theravance Biopharma Investigational Site

Orlando, Florida, United States

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Theravance Biopharma Investigational Site

Ormond Beach, Florida, United States

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Theravance Biopharma Investigational Site

Sarasota, Florida, United States

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Theravance Biopharma Investigational Site

Tampa, Florida, United States

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Theravance Biopharma Investigational Site

Winter Park, Florida, United States

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Theravance Biopharma Investigational Site

Chicago Ridge, Illinois, United States

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Theravance Biopharma Investigational Site

River Forest, Illinois, United States

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Theravance Biopharma Investigational Site

Hammond, Indiana, United States

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Theravance Biopharma Investigational Site

Valparaiso, Indiana, United States

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Theravance Biopharma Investigational Site

Annapolis, Maryland, United States

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Theravance Biopharma Investigational Site

Columbia, Maryland, United States

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Theravance Biopharma Investigational Site

Oxon Hill, Maryland, United States

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Theravance Biopharma Investigational Site

Towson, Maryland, United States

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Theravance Biopharma Investigational Site

North Dartmouth, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Las Vegas, Nevada, United States

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Theravance Biopharma Investigational Site

Albuquerque, New Mexico, United States

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Theravance Biopharma Investigational Site

Bronxville, New York, United States

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Theravance Biopharma Investigational Site

Schenectady, New York, United States

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Theravance Biopharma Investigational Site

Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Huntersville, North Carolina, United States

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Kernersville, North Carolina, United States

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Theravance Biopharma Investigational Site

Monroe, North Carolina, United States

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Theravance Biopharma Investigational Site

Raleigh, North Carolina, United States

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Theravance Biopharma Investigational Site

Winston-Salem, North Carolina, United States

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Theravance Biopharma Investigational Site

Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Theravance Biopharma Investigational Site

Columbus, Ohio, United States

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Theravance Biopharma Investigational Site

Columbus, Ohio, United States

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Theravance Biopharma Investigational Site

Marion, Ohio, United States

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Theravance Biopharma Investigational Site

Grants Pass, Oregon, United States

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Theravance Biopharma Investigational Site

Medford, Oregon, United States

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Theravance Biopharma Investigational Site

Portland, Oregon, United States

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Theravance Biopharma Investigational Site

Anderson, South Carolina, United States

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Theravance Biopharma Investigational Site

Columbia, South Carolina, United States

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Theravance Biopharma Investigational Site

Gaffney, South Carolina, United States

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Theravance Biopharma Investigational Site

Greenville, South Carolina, United States

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Theravance Biopharma Investigational Site

Lexington, South Carolina, United States

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Theravance Biopharma Investigational Site

North Charleston, South Carolina, United States

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Theravance Biopharma Investigational Site

Rock Hill, South Carolina, United States

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Theravance Biopharma Investigational Site #2

Spartanburg, South Carolina, United States

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Theravance Biopharma Investigational Site

Spartanburg, South Carolina, United States

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Theravance Biopharma Investigational Site

Union, South Carolina, United States

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Theravance Biopharma Investigational Site

Franklin, Tennessee, United States

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Theravance Biopharma Investigational Site

Johnson City, Tennessee, United States

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Theravance Biopharma Investigational Site

Knoxville, Tennessee, United States

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Theravance Biopharma Investigational Site

Kerrville, Texas, United States

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Theravance Biopharma Investigational Site

McAllen, Texas, United States

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Theravance Biopharma Investigational Site

San Antonio, Texas, United States

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Theravance Biopharma Investigational Site

Sherman, Texas, United States

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Theravance Biopharma Investigational Site

Webster, Texas, United States

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Theravance Biopharma Investigational Site

Roy, Utah, United States

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Theravance Biopharma Investigational Site

West Valley City, Utah, United States

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Theravance Biopharma Investigational Site

Abingdon, Virginia, United States

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Theravance Biopharma Investigational Site

Spokane, Washington, United States

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Theravance Biopharma Investigational Site

Cudahy, Wisconsin, United States

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Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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0180

Identifier Type: -

Identifier Source: org_study_id