Clinical trial · Interventional
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
NCT00141791CI-TRIAL-00002525completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etanercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).
Secondary outcomes (1)
- measure
- Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHolgate 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 21109557