NCT05165485|CompletedPhase 4ResultsFDA Drug

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

PIFR-2

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®)

Theravance Biopharma ClinicalTrials.gov

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1 other identifier

0180

Study Type

interventional

Target

404

Locations

1 country

Sites

Timeline

RegisteredDec 2021

StartedJan 2022

CompletionNov 2023

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

404

participants targeted

Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease

Timeline

Completed

Started Jan 2022

Geographic Reach

1 country

76 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

December 7, 2021

Completed

14 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed

17 days until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2023

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2024

Completed

Last Updated

December 20, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

December 7, 2021

Results QC Date

November 13, 2024

Last Update Submit

December 17, 2024

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDPeak Inspiratory Flow RatePIFRPulmonary Function

Outcome Measures

Primary Outcomes (1)

FEV1
Change from baseline in forced expiratory volume in one second (FEV1) at trough on Day 85
Baseline, Day 85 following 84 days of dosing

Secondary Outcomes (6)

OTE on FEV1
Baseline, Day 30, Day 60, Day 85
FEV1
Baseline, Day 30
FEV1
Baseline, Day 60
FVC
Baseline, Day 85
80-mL Increase in FEV1 at Trough on Day 85
Baseline, Day 85
+1 more secondary outcomes

Study Arms (2)

Revefenacin

EXPERIMENTAL

Revefenacin administered with Tiotropium Placebo

Drug: RevefenacinDrug: Tiotropium Placebo

Tiotropium

ACTIVE COMPARATOR

Tiotropium administered with Revefenacin Placebo

Drug: TiotropiumDrug: Revefenacin Placebo

Interventions

RevefenacinDRUG

Revefenacin 175 mcg administered once daily for 84 days via nebulization

Also known as: Yupelri®, TD-4208

Revefenacin

TiotropiumDRUG

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

Also known as: Spiriva®

Tiotropium

Revefenacin PlaceboDRUG

Placebo for Revefenacin administered once daily for 84 days via nebulization

Tiotropium

Tiotropium PlaceboDRUG

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

Revefenacin

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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
+3 more criteria

You may not qualify if:

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.
Participant received COVID-19 vaccine within 2 weeks prior to Visit 1.

Contact the study team to confirm eligibility.