A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
This trial is active, not recruiting.
|Condition||chronic obstructive pulmonary disease (copd)|
|Sponsor||Theravance Biopharma R & D, Inc.|
|Start date||September 2015|
|End date||May 2017|
|Trial size||1080 participants|
|Trial identifier||NCT02518139, 0128|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Pulmonary function test following 52 weeks of treatment
time frame: 12 month pulmonary function test
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
|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|
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