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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: TD-4208; Drug: Tiotropium

• Registration Number: NCT02518139
• Lead Sponsor: Mylan Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Study Start: 2015-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Disposition First Submitted: 2018-04-13
• Disposition First Submitted QC: 2018-04-13
• Disposition First Posted: 2018-04-17
• Results First Submitted: 2018-12-06
• Results First Submitted QC: 2018-12-06
• Results First Posted: 2018-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1060

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-4208-1	TD-4208	88 mcg
TD-4208-2	TD-4208	175 mcg
Tiotropium	Tiotropium	18 mcg

Primary Outcome Measures

Name	Time	Method
Adverse Events: Frequency and Severity	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)

Trial Locations

Locations (1)

Palmetto Medical Research Associates L.L.C; 🇺🇸 Easley, South Carolina, United States