Asthma Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma
| Verified date | June 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | November 2005 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Mild to moderate persistent asthma (NAEPP/GINA Step 2-3) - Reversibility to albuterol at least 12% and 200 mL Exclusion Criteria: - Any significant co-morbid disease, particularly cardiovascular - Use of any maintenance therapy except short acting bronchodilators - Smoking history > or = 10 years |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Costa Rica | Pfizer Investigational Site | Barrio Aranjuez | San Jose |
| Costa Rica | Pfizer Investigational Site | San Jose | |
| India | Pfizer Investigational Site | Chennai | Tamil Nadu |
| India | Pfizer Investigational Site | Mumbai | Maharashtra |
| India | Pfizer Investigational Site | Noida | Uttar Pradesh |
| India | Pfizer Investigational Site | Vellore | Tamilnadu |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | DeLand | Florida |
| United States | Pfizer Investigational Site | Encinitas | California |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Lincoln | Rhode Island |
| United States | Pfizer Investigational Site | Madison | Wisconsin |
| United States | Pfizer Investigational Site | Madisonville | Kentucky |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Nashville | Tennessee |
| United States | Pfizer Investigational Site | Normal | Illinois |
| United States | Pfizer Investigational Site | North Dartmouth | Massachusetts |
| United States | Pfizer Investigational Site | Riverside | California |
| United States | Pfizer Investigational Site | Skillman | New Jersey |
| United States | Pfizer Investigational Site | Springfield | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Costa Rica, India,
| 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, disease control and quality of life compared to placebo |
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