A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design 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 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 (forced expiratory volume in 1 second/forced vital capacity) ratio <0.7

• Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)

• Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal

• Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response

• 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 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)