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OpenTrials
Completed

NCT Number: NCT02518139

A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.

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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

Subjects receiving TD-4208 are blinded to one of two doses of 4208.

Other names: revefenacin

Tiotropium

Drug

There is not a placebo, there is an active comparator (Tiotropium) arm.

Primary outcomes

  1. Adverse Events: Frequency and Severity

    Time frame: Baseline to Day 365

    To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study title

A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 7, 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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