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OpenTrials
Completed

NCT Number: NCT02512510

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Palmetto Medical Research Associates L.L.C.

Easley, South Carolina, 29640, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-4208

Drug

Other names: revefenacin

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Trough FEV1 on Day 85

    Time frame: Baseline and Day 85

Secondary outcomes

  1. Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85

    Time frame: Days 15 to 85

  2. Summary of Change From Baseline to Peak FEV1 After First Dose

    Time frame: 0-2 hours after First Dose Day 1

  3. Summary of Rescue Medication Use: Puffs Per Day

    Time frame: 1-3 Months

  4. St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85

    Time frame: Day 85

    A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units

  5. Percentage of Albuterol Rescue-free 24-hour Periods

    Time frame: 1-3 Months

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 31, 2015
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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