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Chronic Obstructive Pulmonary DiseasePhase 4PIFR-2NCT05165485

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

A Phase 4 study testing Revefenacin and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Theravance Biopharma at 76 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Revefenacin and Tiotropium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
76 sitesUnited States
Study dates
7 Jan 2022to 20 Nov 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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 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.
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  • 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.
  • 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.

Who cannot join

  • 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/1.72m^2).
  • 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.
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  • 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.

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Theravance Biopharma Investigational Site

    Abingdon, Virginia, 24210

  • Theravance Biopharma Investigational Site

    Albuquerque, New Mexico, 87108

  • Theravance Biopharma Investigational Site

    Anderson, South Carolina, 29621

  • Theravance Biopharma Investigational Site

    Annapolis, Maryland, 21401

  • Theravance Biopharma Investigational Site

    Brandon, Florida, 33511

  • Theravance Biopharma Investigational Site

    Bronxville, New York, 10708

  • Theravance Biopharma Investigational Site

    Charlotte, North Carolina, 28207

  • Theravance Biopharma Investigational Site

    Chicago Ridge, Illinois, 60415

  • Theravance Biopharma Investigational Site

    Cincinnati, Ohio, 45236

  • Theravance Biopharma Investigational Site

    Cincinnati, Ohio, 45242

  • Theravance Biopharma Investigational Site

    Clearwater, Florida, 33756

  • Theravance Biopharma Investigational Site site 2

    Clearwater, Florida, 33765

  • Theravance Biopharma Investigational Site

    Clearwater, Florida, 33765

  • Theravance Biopharma Investigational Site

    Columbia, Maryland, 21046

  • Theravance Biopharma Investigational Site

    Columbia, South Carolina, 29204

  • Theravance Biopharma Investigational Site

    Columbus, Ohio, 43215

  • Theravance Biopharma Investigational Site

    Columbus, Ohio, 43235

  • Theravance Biopharma Investigational Site

    Cudahy, Wisconsin, 53110

  • Theravance Biopharma Investigational Site

    Daytona Beach, Florida, 32117

  • Theravance Biopharma Investigational Site

    Farmington Hills, Michigan, 48336

  • Theravance Biopharma Investigational Site

    Franklin, Tennessee, 37067

  • Theravance Biopharma Investigational Site

    Gaffney, South Carolina, 29340

  • Theravance Biopharma Investigational Site

    Grants Pass, Oregon, 97527

  • Theravance Biopharma Investigational Site

    Greenville, South Carolina, 29615

  • Theravance Biopharma Investigational Site

    Hammond, Indiana, 46324

  • Theravance Biopharma Investigational Site

    Hickory, North Carolina, 28601

  • Theravance Biopharma Investigational Site

    Huntersville, North Carolina, 28078

  • Theravance Biopharma Investigational Site

    Jasper, Alabama, 35501

  • Theravance Biopharma Investigational Site

    Johnson City, Tennessee, 37601

  • Theravance Biopharma Investigational Site

    Kernersville, North Carolina, 27284

  • Theravance Biopharma Investigational Site

    Kerrville, Texas, 78028

  • Theravance Biopharma Investigational Site

    Knoxville, Tennessee, 37909

  • Theravance Biopharma Investigational Site

    Lakewood, Colorado, 80228

  • Theravance Biopharma Investigational Site

    Las Vegas, Nevada, 89106

  • Theravance Biopharma Investigational Site

    Leesburg, Florida, 34748

  • Theravance Biopharma Investigational Site

    Lexington, South Carolina, 29072

  • Theravance Biopharma Investigational Site

    Marion, Ohio, 43302

  • Theravance Biopharma Investigational Site

    McAllen, Texas, 78503

  • Theravance Biopharma Investigational Site

    Medford, Oregon, 97504

  • Theravance Biopharma Investigational Site

    Miami, Florida, 33155

  • Theravance Biopharma Investigational Site

    Miami, Florida, 33186

  • Theravance Biopharma Investigational Site

    Missoula, Montana, 59808

  • Theravance Biopharma Investigational Site

    Monroe, North Carolina, 28112

  • Theravance Biopharma Investigational Site

    Newport Beach, California, 92663

  • Theravance Biopharma Investigational Site

    North Charleston, South Carolina, 29406

  • Theravance Biopharma Investigational Site

    North Dartmouth, Massachusetts, 02747

  • Theravance Biopharma Investigational Site

    Orlando, Florida, 32825

  • Theravance Biopharma Investigational Site

    Ormond Beach, Florida, 32174

  • Theravance Biopharma Investigational Site

    Oxon Hill, Maryland, 20745

  • Theravance Biopharma Investigational Site

    Phoenix, Arizona, 85018

  • Theravance Biopharma Investigational Site

    Portland, Oregon, 97202

  • Theravance Biopharma Investigational Site

    Raleigh, North Carolina, 27607

  • Theravance Biopharma Investigational Site

    River Forest, Illinois, 60305

  • Theravance Biopharma Investigational Site

    Rock Hill, South Carolina, 29732

  • Theravance Biopharma Investigational Site

    Roy, Utah, 84067

  • Theravance Biopharma Investigational Site

    Saint Charles, Missouri, 63301

  • Theravance Biopharma Investigational Site

    San Antonio, Texas, 78229

  • Theravance Biopharma Investigational Site

    San Diego, California, 92120

  • Theravance Biopharma Investigational Site

    Sarasota, Florida, 34239

  • Theravance Biopharma Investigational Site

    Schenectady, New York, 12308

  • Theravance Biopharma Investigational Site

    Sherman, Texas, 75092

  • Theravance Biopharma Investigational Site #2

    Spartanburg, South Carolina, 29303

  • Theravance Biopharma Investigational Site

    Spartanburg, South Carolina, 29303

  • Theravance Biopharma Investigational Site

    Spokane, Washington, 99204

  • Theravance Biopharma Investigational Site

    St Louis, Missouri, 63141

  • Theravance Biopharma Investigational Site

    Stockton, California, 95207

  • Theravance Biopharma Investigational Site

    Tampa, Florida, 33606

  • Theravance Biopharma Investigational Site

    Towson, Maryland, 21286

  • Theravance Biopharma Investigational Site

    Tucson, Arizona, 85715

  • Theravance Biopharma Investigational Site

    Union, South Carolina, 29379

  • Theravance Biopharma Investigational Site

    Upland, California, 91786

  • Theravance Biopharma Investigational Site

    Valparaiso, Indiana, 46383

  • Theravance Biopharma Investigational Site

    Webster, Texas, 77598

  • Theravance Biopharma Investigational Site

    West Valley City, Utah, 84120

  • Theravance Biopharma Investigational Site

    Winston-Salem, North Carolina, 27103

  • Theravance Biopharma Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

About this study

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®)

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.

Being tested
Revefenacin, Tiotropium, Revefenacin Placebo, Tiotropium Placebo
Keywords
COPD, Peak Inspiratory Flow Rate, PIFR, Pulmonary Function
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RevefenacinDrug

    Also called Yupelri®, TD-4208

    Revefenacin 175 mcg administered once daily for 84 days via nebulization

  • TiotropiumDrug

    Also called Spiriva®

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

  • Revefenacin PlaceboDrug

    Placebo for Revefenacin administered once daily for 84 days via nebulization

  • Tiotropium PlaceboDrug

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

Study groups in NCT05165485
Study groupRoleWhat they receive
RevefenacinExperimentalRevefenacin administered with Tiotropium Placebo
Receives: Drug: Revefenacin; Drug: Tiotropium Placebo
TiotropiumActive comparatorTiotropium administered with Revefenacin Placebo
Receives: Drug: Tiotropium; Drug: Revefenacin Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1

    Change from baseline in forced expiratory volume in one second (FEV1) at trough on Day 85

    Measured: Baseline, Day 85 following 84 days of dosing

Secondary outcomes (6)

  1. OTE on FEV1

    Trough Overall Treatment Effect (OTE) on FEV1. Overall is defined as the average change from baseline at trough across Day 30, Day 60, and Day 85.

    Measured: Baseline, Day 30, Day 60, Day 85

  2. FEV1

    Change from baseline in FEV1 at trough on Day 30

    Measured: Baseline, Day 30

  3. FEV1

    Change from baseline in FEV1 at trough on Day 60

    Measured: Baseline, Day 60

  4. FVC

    Change from baseline in forced vital capacity (FVC) at trough on Day 85

    Measured: Baseline, Day 85

  5. 80-mL Increase in FEV1 at Trough on Day 85

    Participants with an 80-mL or greater change from baseline FEV1 at trough were counted as responders. Participants with change from baseline FEV1 < 80 mL and participants with change from baseline FEV1 not obtained were counted as nonresponders.

    Measured: Baseline, Day 85

  6. First Occurrence of CompEx Event

    Count of participants experiencing events and time from first dose to first occurrence of a composite endpoint for exacerbations of COPD (CompEx) event were evaluated. The statistical analysis is a Cox proportional hazards model analysis of time to first event and the Revefenacin / Tiotropium hazard ratio is calculated and reported. Data are reported as the numbers of subjects with events and the hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

    CompEx events are a composite of moderate or severe COPD exacerbation, premature termination from the study for any reason other than Sponsor decision, and clinically relevant deterioration in COPD. Clinically relevant deterioration events are defined as increases in COPD symptoms meeting specified criteria based on participant diary data.

    Measured: Date of first dose through date of last dose + 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start7 Jan 2022
  3. Primary completion13 Nov 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165485
Sponsor's protocol ID
0180
Acronym
PIFR-2
Status last verified
Nov 2024
First submitted
7 Dec 2021
Last updated
20 Dec 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Revefenacin and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Theravance Biopharma at 76 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 (time frame: Baseline, Day 85 following 84 days of dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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