CompletedPhase 4

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

United States404 participantsStarted 2022-01-07

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✓. 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.
✓. 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.
✓. 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.

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/1.72m\^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.
✕. 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.

What they're measuring

FEV1

Timeframe: Baseline, Day 85 following 84 days of dosing

Trial details

NCT IDNCT05165485

SponsorTheravance Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-13

Results submitted2024-11-13

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