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
1 other identifier
interventional
120
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started May 2005
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedAugust 7, 2009
August 1, 2009
1.2 years
August 30, 2005
August 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Secondary Outcomes (1)
Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Previous treatment with etanercept
- Current use of cigarettes
- Significant concurrent medical conditions at the time of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Denver, Colorado, 80206, United States
Unknown Facility
Sarasota, Florida, 34233, United States
Unknown Facility
Tallahassee, Florida, 32308, United States
Unknown Facility
Valrico, Florida, 33594, United States
Unknown Facility
Covington, Louisiana, 70433, United States
Unknown Facility
Wheaton, Maryland, 20902, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Rockville Centre, New York, 11570, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Richmond, Virginia, 23229, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 21109557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
May 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
August 7, 2009
Record last verified: 2009-08