Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD
| Verified date | May 2013 |
| Source | Dey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.
| Status | Completed |
| Enrollment | 468 |
| Est. completion date | October 2011 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Days and older |
| Eligibility |
Inclusion Criteria: - Able to understand the requirements of the study and provide written informed consent - A clinical diagnosis of COPD - A current or prior history of at least 10-pack years of cigarette smoking - Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study Exclusion Criteria: - A clinical diagnosis of Asthma - Other significant disease than COPD - Subjects who radiation or chemotherapy within the previous 12 months - Subjects who had any lung resection - QTcB greater than 0.460 seconds - History of illegal drug abuse or alcohol abuse within the past 5 years |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigative Site | Charlotte | North Carolina |
| United States | Investigative Site | Clearwater | Florida |
| United States | Investigative Site | Coeur D'Alene | Idaho |
| United States | Investigative Site | Deland | Florida |
| United States | Investigative Site | Easley | South Carolina |
| United States | Investigative Site | Fullerton | California |
| United States | Investigative Site | Gaffney | South Carolina |
| United States | Investigative Site | Greenville | South Carolina |
| United States | Investigative Site | Greer | South Carolina |
| United States | Investigative Site | Lawrenceville | Georgia |
| United States | Investigative Site | Madisonville | Kentucky |
| United States | Investigative Site | Medford | Oregon |
| United States | Investigative Site | Phoenix | Arizona |
| United States | Investigative Site | Raleigh | North Carolina |
| United States | Investigative Site | Saint Louis | Missouri |
| United States | Investigative Site | San Antonio | Texas |
| United States | Investigative Site | San Diego | California |
| United States | Investigative Site | Spartanburg | South Carolina |
| United States | Investigative Site | Spokane | Washington |
| United States | Investigative Site | Sunset | Louisiana |
| United States | Investigative site | Sylvania | Ohio |
| United States | Investigative Site | Tamarac | Florida |
| United States | Invesigative Site | Union | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Dey |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD | 12 Weeks | Yes | |
| Secondary | Incidence of adverse events (AEs) | 12 Weeks | Yes |
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