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 in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
| Verified date | April 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 | September 2006 |
| Est. primary completion date | September 2005 |
| 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 | Albuquerque | New Mexico |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Buena Park | California |
| United States | Research Site | Butte | Montana |
| 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 | Clearwater | Florida |
| United States | Research Site | Columbus | Ohio |
| 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 | Florence | Kentucky |
| United States | Research Site | Hartford | Connecticut |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Hines | Illinois |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | Normal | Illinois |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | Minnesota |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| 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 | Stockton | California |
| United States | Research Site | Summit | New Jersey |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tuscon | Arizona |
| United States | Research Site | Wheat Ridge | Colorado |
| United States | Research Site | Woodstock | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Dey |
United States,
Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. — View Citation
Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K; Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled — View Citation
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|---|---|---|---|---|
| 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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