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The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study


N/A
18 Years
65 Years
Not Enrolling
Both
Asthma

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Trial Information

The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Methacholine PC20

Principal Investigator

Michael A Berry, MB, ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute for Lung Health

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

etanercept/pr2

NCT ID:

NCT00276029

Start Date:

December 2003

Completion Date:

September 2004

Related Keywords:

  • Asthma
  • Asthma
  • Refractory
  • Asthma

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