Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) (COPD)

February 22, 2022 updated by: Mylan Inc.

A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

619

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97202
        • Allergy Associates Research Center (AARC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

  • Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
ACTIVE_COMPARATOR: TD-4208-1
88 mcg
Drug: TD-4208
Other Names:
  • revefenacin
ACTIVE_COMPARATOR: TD-4208-2
175 mcg
Drug: TD-4208
Other Names:
  • revefenacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Trough FEV1 on Day 85
Time Frame: Day 85
Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
Time Frame: Days 15 to 85
Days 15 to 85
Summary of Change From Baseline to Peak FEV1 After First Dose
Time Frame: 0-2 hours after First Dose Day 1
0-2 hours after First Dose Day 1
Summary of Rescue Medication Use: Puffs Per Day
Time Frame: 1-3 Months
1-3 Months
Percentage of Albuterol Rescue-free 24-hour Periods
Time Frame: 1-3 Months
1-3 Months
St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
Time Frame: Baseline to Day 85
A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units
Baseline to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (ESTIMATE)

June 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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