This trial has been completed.

Condition chronic obstructive pulmonary disease (copd)
Treatment td-4208
Phase phase 3
Sponsor Theravance Biopharma R & D, Inc.
Start date September 2015
End date August 2016
Trial size 645 participants
Trial identifier NCT02512510, 0127


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.

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
(Active Comparator)
88 mcg
td-4208 revefenacin
(Active Comparator)
175 mcg
td-4208 revefenacin
(Placebo Comparator)
td-4208 revefenacin

Primary Outcomes

Pulmonary function test following 12 weeks of treatment
time frame: 3 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, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study 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..