Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease
| Verified date | June 2009 |
| Source | Dey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
| Status | Completed |
| Enrollment | 457 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of COPD - Female of child-bearing potential to use adequate birth control - Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day - Meet lung function requirements Exclusion Criteria: - Diagnosis of asthma - Other significant disease than COPD - Pregnant or lactating female - Female planning to become pregnant |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Abingdon | Virginia |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Buena Park | California |
| United States | Research Site | Camillus | New York |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Cherry Hill | New Jersey |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Coeur d'Alene | Idaho |
| United States | Research Site | Costa Mesa | California |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | Encinitas | California |
| United States | Research Site | Greenville | North Carolina |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hines | Illinois |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Lenexa | Kansas |
| United States | Research Site | Liverpool | New York |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Madisonville | Kentucky |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Morrisville | North Carolina |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | South Burlington | Vermont |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | St. Charles | Missouri |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tamarac | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Wheat Ridge | Colorado |
| United States | Research Site | Wheaton | Maryland |
| United States | Research Site | Woodstock | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Dey |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 2-hour post-dose FEV1 | 2 weeks | No | |
| Primary | AUC(0-12) and Cmax in plasma | 2 weeks | Yes | |
| Primary | pre-dose FEV1 | 2 weeks | No | |
| Primary | Amount and percent total dose excreted in urine | 2 weeks | Yes | |
| Secondary | FEV1 AUC(0-2) | 2 weeks | No | |
| Secondary | COPD exacerbations | |||
| Secondary | Treatment Emergent Adverse Events | 2 weeks | Yes |
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