A 7-Day Cross-over Study of QD and BID TD-4208 in COPD
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 5/5/2014 |
| Start Date: | April 2014 |
| End Date: | September 2014 |
| Contact: | Andrew Nicholls, MD |
| Email: | anicholls@theravance.com |
| Phone: | 650-808-6400 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Cross-Over Study of QD and BID Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
This study will evaluate 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.
when administered using a jet nebulizer for 7 days in a cross-over design to patients with
moderate to severe chronic obstructive pulmonary disease.
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 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 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)
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