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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

NCT ID: NCT03573817

Last Updated: 2022-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2018-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Period 1: Revefenacin + Formoterol (Sequential)

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

Group Type EXPERIMENTAL

Revefenacin

Intervention Type DRUG

Revefenacin is administered via a nebulizer.

Formoterol

Intervention Type DRUG

Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Period 2: Revefenacin + Formoterol (Combo Solution)

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.

Group Type EXPERIMENTAL

Revefenacin

Intervention Type DRUG

Revefenacin is administered via a nebulizer.

Formoterol

Intervention Type DRUG

Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Period 1: Placebo + Formoterol (Sequential)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo version of Revefenacin is administered via a nebulizer.

Formoterol

Intervention Type DRUG

Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Period 2: Placebo + Formoterol (Combo Solution)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo version of Revefenacin is administered via a nebulizer.

Formoterol

Intervention Type DRUG

Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Interventions

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Revefenacin

Revefenacin is administered via a nebulizer.

Intervention Type DRUG

Placebo

Placebo version of Revefenacin is administered via a nebulizer.

Intervention Type DRUG

Formoterol

Administered sequentially in both revefenacin and placebo arms using a nebulizer.

Intervention Type DRUG

Other Intervention Names

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TD-4208

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theravance Biopharma

INDUSTRY

Sponsor Role collaborator

Mylan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

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Theravance Biopharma Investigational Site

Miami, Florida, United States

Site Status

Theravance Biopharma Investigational Site

Orlando, Florida, United States

Site Status

Theravance Biopharma Investigational Site

Sarasota, Florida, United States

Site Status

Theravance Biopharma Investigational Site

Tampa, Florida, United States

Site Status

Theravance Biopharma Investigational Site

Saint Charles, Missouri, United States

Site Status

Theravance Biopharma Investigational Site

Monroe, North Carolina, United States

Site Status

Theravance Biopharma Investigational Site

Columbus, Ohio, United States

Site Status

Theravance Biopharma Investigational Site

Medford, Oregon, United States

Site Status

Theravance Biopharma Investigational Site

Erie, Pennsylvania, United States

Site Status

Theravance Biopharma Investigational Site

Gaffney, South Carolina, United States

Site Status

Theravance Biopharma Investigational Site

Greenville, South Carolina, United States

Site Status

Theravance Biopharma Investigational Site

Spartanburg, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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0167

Identifier Type: -

Identifier Source: org_study_id

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