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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.; Theravance Biopharma R & D, Inc.
• Collaborator: Theravance Biopharma

Criteria

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)