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TNF Alpha in Refractory 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: NCT00276029
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : May 4, 2006
Information provided by:
University Hospitals, Leicester

Brief Summary:
The purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways

Condition or disease Intervention/treatment Phase
Asthma Drug: Etanercept Not Applicable

Detailed Description:

Although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. Treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending.

This randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study
Study Start Date : December 2003
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Etanercept

Primary Outcome Measures :
  1. Methacholine PC20
  2. Juniper asthma quality of life

Secondary Outcome Measures :
  1. Net change in post-bronchodilator FEV1
  2. FEF25-75
  3. FVC
  4. symptom visual analogue score
  5. exhaled nitric oxide concentration
  6. computed alveolar nitric oxide concentration
  7. sputum differential inflammatory cell counts
  8. sputum supernatant mediator concentration.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic asthma Methacholine PC20<8mg/ml

Exclusion Criteria:

  • History of poor treatment concordance History of tuberculosis Radiographic evidence of previous tuberculosis Recent tuberculosis contact Respiratory tract infection within 3 months Current Smoker or Ex-smoker with more than 5 pack years Symptomatic co-morbid condition Contra-indication to etanercept Pregancy Breast feeding

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): NCT00276029

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United Kingdom
Institute for Lung Health
Leicester, Leicestershire, United Kingdom, LE3 9QP
Sponsors and Collaborators
University Hospitals, Leicester
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Principal Investigator: Michael A Berry, MB, ChB Institute for Lung Health
Publications of Results:
Layout table for additonal information Identifier: NCT00276029    
Other Study ID Numbers: etanercept/pr2
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: May 4, 2006
Last Verified: September 2004
Keywords provided by University Hospitals, Leicester:
Additional relevant MeSH terms:
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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