Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatment td-4208
Phase phase 3
Sponsor Theravance Biopharma R & D, Inc.
Start date September 2015
End date May 2017
Trial size 1080 participants
Trial identifier NCT02518139, 0128

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
88 mcg
td-4208 revefenacin
(Active Comparator)
175 mcg
td-4208 revefenacin
(Active Comparator)
18 mcg
td-4208 revefenacin

Primary Outcomes

Measure
Pulmonary function test following 52 weeks of treatment
time frame: 12 month pulmonary function test

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Theravance Biopharma R & D, Inc..