A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma
Phase 2
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
Asthma
Both
Asthma
Trial Information
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma
Inclusion Criteria:
- Moderate to severe persistent asthma for at least 1 year
- Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
- Subjects must be on a high-dose inhaled corticosteroid (ICS)
Exclusion Criteria:
- Previous treatment with etanercept
- Current use of cigarettes
- Significant concurrent medical conditions at the time of screening
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
0881A8-205
NCT ID:
NCT00141791
Start Date:
May 2005
Completion Date:
July 2006
Related Keywords:
- Asthma
- Asthma
- Anti-Asthmatic Agents
- Receptors
- Tumor Necrosis Factor
- Asthma
Name | Location |
|---|---|
| Birmingham, Alabama 35294 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| McLean, Virginia 22101 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin |
