Study Evaluating Etanercept in Moderate to Severe Asthma

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT00141791
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).

Secondary Outcome Measures

Name	Time	Method
Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.