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
Not Enrolling
Both
Asthma

Thank you

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