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NCT02518139 Clinical Trial

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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02518139
Other study ID # 0128
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2015
Est. completion date June 2017

Study information
Verified date February 2022
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1060
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TD-4208
Subjects receiving TD-4208 are blinded to one of two doses of 4208.
• Tiotropium
There is not a placebo, there is an active comparator (Tiotropium) arm.

Locations
Country Name City State
United States Palmetto Medical Research Associates L.L.C Easley South Carolina

Sponsors (2)
Lead Sponsor Collaborator
Mylan Inc. Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events: Frequency and Severity To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE) Baseline to Day 365
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