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

Mylan

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Tiotropium; Drug: TD-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02518139

0128

Details and patient eligibility

About

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.

Enrollment: 1,060 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,060 participants in 3 patient groups

TD-4208-1

Experimental group

Description:

88 mcg

Treatment:

Drug: TD-4208

TD-4208-2

Experimental group

Description:

175 mcg

Treatment:

Drug: TD-4208

Tiotropium

Active Comparator group

Description:

18 mcg

Treatment:

Drug: Tiotropium