Study Evaluating Etanercept in Moderate to Severe Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141791
• Other study ID #: 0881A8-205
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: August 6, 2009
• Start date: May 2005
• Est. completion date: July 2006

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Secondary	Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.