This is an initial proof of concept, phase to study to assess the safety and efficacy of a novel anti-inflammatory agent for the chronic maintenance treatment of adults with persistent asthma

Condition	Intervention	Phase
Asthma	Drug: Investigational Study Drug	Phase II

Further Study Details: 

Primary Outcomes: Change from baseline in FEV1 compared to placebo
Secondary Outcomes: Change from baseline in other lung function parameters, disease control and quality of life compared to placebo
Expected Total Enrollment:  112

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00150397

Pfizer CT.gov Call Center      1-800-718-1021 

California
      Pfizer Investigational Site, Encinitas,  California,  92024,  United States; Recruiting
      Pfizer Investigational Site, Riverside,  California,  92506,  United States; Completed
Georgia
      Pfizer Investigational Site, Atlanta,  Georgia,  30281,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Normal,  Illinois,  61761,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, North Dartmouth,  Massachusetts,  02747,  United States; Recruiting
Minnesota
      Pfizer Investigational Site, Minneapolis,  Minnesota,  55402,  United States; Recruiting
New Jersey
      Pfizer Investigational Site, Skillman,  New Jersey,  08558,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Cincinnati,  Ohio,  45241,  United States; Recruiting
Rhode Island
      Pfizer Investigational Site, Lincoln,  Rhode Island,  02865,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Kingsport,  Tennessee,  37660,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States; Recruiting
Texas
      Pfizer Investigational Site, Dallas,  Texas,  75231,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53792,  United States; Recruiting
Costa Rica
      Pfizer Investigational Site, San Jose,  Costa Rica; Recruiting
      Pfizer Investigational Site, San Jose,  Costa Rica; Recruiting
Costa Rica, San Jose
      Pfizer Investigational Site, Barrio Aranjuez,  San Jose,  Costa Rica; Recruiting
India, Maharashtra
      Pfizer Investigational Site, Mumbai,  Maharashtra,  400 014,  India; Recruiting
India, Tamil Nadu
      Pfizer Investigational Site, Chennai,  Tamil Nadu,  600 034,  India; Recruiting
India, Tamilnadu
      Pfizer Investigational Site, Vellore,  Tamilnadu,  632002,  India; Recruiting
India, Uttar Pradesh
      Pfizer Investigational Site, Noida,  Uttar Pradesh,  201301,  India; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A2641021
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150397
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13