Clinical Trial: A Phase 2 Study of the Safety and Efficacy of a Novel Anti-Inflammatory Investigational Drug in Adult Asthmatics

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00150397

Purpose

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

MedlinePlus related topics:  Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study of the Efficacy and Safety of an Investigational New Product in Adults with Persistent Asthma.

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

Study start: March 2005

Eligibility

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

Location and Contact Information

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   

More Information

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

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