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Phase 4 COPD and Suboptimal Inspiratory Flow Rate (PIFR-2)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Revefenacin
Tiotropium
Revefenacin Placebo
Tiotropium Placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Peak Inspiratory Flow Rate, PIFR, Pulmonary Function

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 postipratropium FEV1 < 50% of predicted normal (using National Health and Nutrition Examination Survey-predicted equations) 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/1.72m2).
  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.

Sites / Locations

  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance BiopharmaRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
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  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
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  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
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  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
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  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational Site #2Recruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting
  • Theravance Biopharma Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Revefenacin

Tiotropium

Arm Description

Revefenacin DoseA administered with tiotropium placebo

Tiotropium DoseB administered with revefenacin placebo

Outcomes

Primary Outcome Measures

FEV1
Change from baseline in trough FEV1

Secondary Outcome Measures

OTE on FEV1
Trough Overall treatment effect (OTE) on FEV1
80-mL improvement in trough FEV1
Percentage of participants who achieve at least an 80-mL improvement in trough FEV1
FVC
Change from baseline in Trough FVC
Average Daily Rescue Albuterol MDI usage
Average Daily Rescue Albuterol MDI usage based on the average number of puffs per day over the treatment period

Full Information

First Posted
December 7, 2021
Last Updated
May 4, 2022
Sponsor
Theravance Biopharma
Collaborators
Mylan Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05165485
Brief Title
Phase 4 COPD and Suboptimal Inspiratory Flow Rate
Acronym
PIFR-2
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 Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
Collaborators
Mylan Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Peak Inspiratory Flow Rate, PIFR, Pulmonary Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
366 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Revefenacin
Arm Type
Experimental
Arm Description
Revefenacin DoseA administered with tiotropium placebo
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
Tiotropium DoseB administered with revefenacin placebo
Intervention Type
Drug
Intervention Name(s)
Revefenacin
Other Intervention Name(s)
Yupelri
Intervention Description
Revefenacin DoseA
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium DoseB
Intervention Type
Drug
Intervention Name(s)
Revefenacin Placebo
Intervention Description
Placebo for Revefenacin administered with Tiotropium
Intervention Type
Drug
Intervention Name(s)
Tiotropium Placebo
Intervention Description
Placebo for Tiotropium administered with Revefenacin
Primary Outcome Measure Information:
Title
FEV1
Description
Change from baseline in trough FEV1
Time Frame
Day 85 following 84 days of dosing
Secondary Outcome Measure Information:
Title
OTE on FEV1
Description
Trough Overall treatment effect (OTE) on FEV1
Time Frame
Baseline through Day 85
Title
80-mL improvement in trough FEV1
Description
Percentage of participants who achieve at least an 80-mL improvement in trough FEV1
Time Frame
Day 85
Title
FVC
Description
Change from baseline in Trough FVC
Time Frame
Day 85
Title
Average Daily Rescue Albuterol MDI usage
Description
Average Daily Rescue Albuterol MDI usage based on the average number of puffs per day over the treatment period
Time Frame
Baseline through Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Monitor
Phone
1-855-633-8479
Email
medinfo@theravance.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Theravance Biopharma Investigational Site
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Lexington
State/Province
South Carolina
ZIP/Postal Code
29072
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site #2
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Theravance Biopharma Investigational Site
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

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