COPD Clinical Trial
Official title:
A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
| Verified date | February 2008 |
| Source | Dey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
| Status | Completed |
| Enrollment | 345 |
| Est. completion date | May 2007 |
| Est. primary completion date | July 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Medical diagnosis of COPD - Current or prior history of cigarette smoking Exclusion Criteria: - Medical diagnosis of asthma - Chest X-ray diagnostic of significant disease other than COPD - Significant condition or disease other than COPD |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy 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 | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| 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 | 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 | Cranston | Rhode Island |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Elizabeth City | North Carolina |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hines | Illinois |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Miami Beach | Florida |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | N. Dartmouth | Massachusetts |
| United States | Research Site | Normal | Illinois |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Overland Park | Kansas |
| 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 | Rochester | Minnesota |
| United States | Research Site | San Diego | California |
| United States | Research Site | Shawnee Mission | Kansas |
| United States | Research Site | South Burlington | Vermont |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Stockton | California |
| United States | Research Site | Summit | New Jersey |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Upland | Pennsylvania |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Dey |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of lung function | |||
| Secondary | Change in lung function, as well as vital signs | |||
| Secondary | Physical Exam results, adverse event reporting, etc |
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