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CompletedNCT00141791Updated Aug 7, 2009

Study Evaluating Etanercept in Moderate to Severe Asthma

A Phase 2 interventional study of Etanercept in Asthma, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 13 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-08-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Anti-Asthmatic Agents
  • Receptors
  • Tumor Necrosis Factor
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 120 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Previous treatment with etanercept
  • Current use of cigarettes
  • Significant concurrent medical conditions at the time of screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
120 participants

Interventions

  • DrugEtanercept
06

What researchers measure

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.

07

Study locations

13 sites
  • Birmingham, Alabama 35209, United States
  • Denver, Colorado 80206, United States
  • Sarasota, Florida 34233, United States
  • Tallahassee, Florida 32308, United States
  • Valrico, Florida 33594, United States
  • Covington, Louisiana 70433, United States
  • Wheaton, Maryland 20902, United States
  • Boston, Massachusetts 02115, United States
  • Rockville Center, New York 11570, United States
  • Winston-Salem, North Carolina 27157, United States
  • Portland, Oregon 97213, United States
  • Richmond, Virginia 23229, United States
  • Madison, Wisconsin 53792, United States
08

References and documents

Publications

  • 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. PubMed 21109557 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00141791
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Sep 1, 2005
Start date
May 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Aug 7, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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