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A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Revefenacin
Placebo
Formoterol
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, Pulmonary Function, COPD, Performist

Eligibility Criteria

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

Inclusion Criteria:

  • Participant is a male or female subject 40 years of age or older.
  • Participant is willing and able to provide signed and dated written informed consent.
  • Participant has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.
  • Participant must be willing and able to attend study visits according to the visit schedule and adhere to all study assessments/procedures.

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, tolerability, or pharmacokinetics of the study drug.
  • Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics, short-acting beta-agonists and long-acting beta-agonists.
  • Participant with clinically significant and uncontrolled hypertension, hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.
  • Participant is unwilling or unable to stop the use of prohibited medications during the washout (if required) and treatment period and follow-up period of the study.

Sites / Locations

  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site
  • Theravance Biopharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Period 1: Revefenacin + Formoterol (Sequential)

Period 2: Revefenacin + Formoterol (Combo Solution)

Period 1: Placebo + Formoterol (Sequential)

Period 2: Placebo + Formoterol (Combo Solution)

Arm Description

Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.

Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening.

Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.

Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening.

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: Death Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe Inpatient hospitalization or prolongation of existing hospitalization Congenital anomaly in the offspring of a participant who received study drug Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Number of Participants With Clinically Relevant Changes in Vital Sign Measurements
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Number of Participants With Clinically Relevant Changes in Electrocardiogram Results
Clinically relevant changes identified based on change from baseline.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2018
Last Updated
February 22, 2022
Sponsor
Mylan Inc.
Collaborators
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT03573817
Brief Title
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Official Title
A Phase 3b, 42-day, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized Revefenacin and Nebulized Formoterol Fumarate (PERFOROMIST®) Administered in Sequence and as a Combined Solution in Subjects With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease, Pulmonary Function, COPD, Performist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Period 1: Revefenacin + Formoterol (Sequential)
Arm Type
Experimental
Arm Description
Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.
Arm Title
Period 2: Revefenacin + Formoterol (Combo Solution)
Arm Type
Experimental
Arm Description
Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening.
Arm Title
Period 1: Placebo + Formoterol (Sequential)
Arm Type
Placebo Comparator
Arm Description
Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening.
Arm Title
Period 2: Placebo + Formoterol (Combo Solution)
Arm Type
Placebo Comparator
Arm Description
Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening.
Intervention Type
Drug
Intervention Name(s)
Revefenacin
Other Intervention Name(s)
TD-4208
Intervention Description
Revefenacin is administered via a nebulizer.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo version of Revefenacin is administered via a nebulizer.
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Administered sequentially in both revefenacin and placebo arms using a nebulizer.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event
Description
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
Time Frame
Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Title
Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event
Description
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: Death Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe Inpatient hospitalization or prolongation of existing hospitalization Congenital anomaly in the offspring of a participant who received study drug Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Time Frame
Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Title
Number of Participants With Clinically Relevant Changes in Vital Sign Measurements
Description
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Time Frame
Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Title
Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements
Description
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Time Frame
Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)
Title
Number of Participants With Clinically Relevant Changes in Electrocardiogram Results
Description
Clinically relevant changes identified based on change from baseline.
Time Frame
Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)

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 subject 40 years of age or older. Participant is willing and able to provide signed and dated written informed consent. Participant has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. Participant must be willing and able to attend study visits according to the visit schedule and adhere to all study assessments/procedures. 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, tolerability, or pharmacokinetics of the study drug. Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics, short-acting beta-agonists and long-acting beta-agonists. Participant with clinically significant and uncontrolled hypertension, hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator. Participant is unwilling or unable to stop the use of prohibited medications during the washout (if required) and treatment period and follow-up period of the study.
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
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Theravance Biopharma Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

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

A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD

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