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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
  Purpose

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 Intervention Phase
Asthma
Drug: Etanercept
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

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

Estimated Enrollment: 120
Study Start Date: May 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141791

Locations
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00141791     History of Changes
Other Study ID Numbers: 0881A8-205
Study First Received: August 30, 2005
Last Updated: August 6, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014