Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

Mylan

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: TD-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02459080

0126

Details and patient eligibility

About

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.

Enrollment: 619 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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619 participants in 3 patient groups, including a placebo group

TD-4208-1

Active Comparator group

Description:

88 mcg

Treatment:

Drug: TD-4208

TD-4208-2

Active Comparator group

Description:

175 mcg

Treatment:

Drug: TD-4208

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo