Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease
| Verified date | November 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | July 2005 |
| Est. primary completion date | July 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Moderate-severe COPD (GOLD 2003 definition) - Smoking history of at least 10 pack-years Exclusion Criteria: - Any significant co-morbid disease, particularly cardiovascular - Use of any maintenance therapy except short acting bronchodilators |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | La Plata | Buenos Aires |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fe |
| Argentina | Pfizer Investigational Site | Vicente Lopez | Buenos Aires |
| Brazil | Pfizer Investigational Site | Curitiba | PR |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Chile | Pfizer Investigational Site | Providencia | Santiago |
| Chile | Pfizer Investigational Site | Recoleta | Santiago |
| Chile | Pfizer Investigational Site | Santiago | |
| Chile | Pfizer Investigational Site | ValparaÃ-so | |
| Costa Rica | Pfizer Investigational Site | San Jose | |
| Mexico | Pfizer Investigational Site | México | D.f. |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo León |
| United States | Pfizer Investigational Site | Bellingham | Washington |
| United States | Pfizer Investigational Site | Buffalo | New York |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Edina | Minnesota |
| United States | Pfizer Investigational Site | Iowa City | Iowa |
| United States | Pfizer Investigational Site | Lake Oswego | Oregon |
| United States | Pfizer Investigational Site | Lincoln | Rhode Island |
| United States | Pfizer Investigational Site | Madisonville | Kentucky |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Normal | Illinois |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Renton | Washington |
| United States | Pfizer Investigational Site | Riverdale | Georgia |
| United States | Pfizer Investigational Site | Riverside | California |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Stockbridge | Georgia |
| United States | Pfizer Investigational Site | Tukwila | Washington |
| United States | Pfizer Investigational Site | Wheaton | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Brazil, Chile, Costa Rica, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in FEV1 compared to placebo | |||
| Secondary | Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo |
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