Study Evaluating Etanercept in Moderate to Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141791
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 7, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Etanercept Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Etanercept

Primary Outcome Measures :
  1. Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).

Secondary Outcome Measures :
  1. Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141791

United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Colorado
Denver, Colorado, United States, 80206
United States, Florida
Sarasota, Florida, United States, 34233
Tallahassee, Florida, United States, 32308
Valrico, Florida, United States, 33594
United States, Louisiana
Covington, Louisiana, United States, 70433
United States, Maryland
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New York
Rockville Center, New York, United States, 11570
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Portland, Oregon, United States, 97213
United States, Virginia
Richmond, Virginia, United States, 23229
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00141791     History of Changes
Other Study ID Numbers: 0881A8-205
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Anti-Asthmatic Agents
Tumor Necrosis Factor

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors