Study Evaluating Etanercept in Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00141791
First received: August 30, 2005
Last updated: August 6, 2009
Last verified: August 2009

August 30, 2005
August 6, 2009
May 2005
July 2006   (final data collection date for primary outcome measure)
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Same as current
Complete list of historical versions of study NCT00141791 on ClinicalTrials.gov Archive Site
Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
Same as current
Not Provided
Not Provided
 
Study Evaluating Etanercept in Moderate to Severe Asthma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: Etanercept
Not Provided
Holgate ST, Noonan M, Chanez P, Busse W, Dupont L, Pavord I, Hakulinen A, Paolozzi L, Wajdula J, Zang C, Nelson H, Raible D. Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. Eur Respir J. 2011 Jun;37(6):1352-9. doi: 10.1183/09031936.00063510. Epub 2010 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141791
0881A8-205
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP