A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Mylan

Status and phase: Completed; Phase 2

Conditions: COPD

Treatments: Drug: Placebo; Drug: TD-4208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040792

0117

Details and patient eligibility

About

This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Enrollment: 355 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
• Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
• Subject is capable of performing reproducible spirometry maneuvers
• Subject has post-bronchodilator FEV1/FVC ratio <0.7
• Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
• Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
• Subject has a current or past smoking history of at least 10 pack-years.

Exclusion criteria

• Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
• Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
• Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
• Subject has been hospitalized for COPD or pneumonia within 12 weeks
• Subject requires long-term oxygen therapy (>15 hours a day)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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355 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

44 mcg

Experimental group

Description:

TD-4208

Treatment:

Drug: TD-4208

88 mcg

Experimental group

Description:

TD-4208

Treatment:

Drug: TD-4208

175 mcg

Experimental group

Description:

TD-4208

Treatment:

Drug: TD-4208

350 mcg

Experimental group

Description:

TD-4208

Treatment:

Drug: TD-4208