TNF Alpha in Refractory Asthma
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
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|
- Methacholine PC20
- Juniper asthma quality of life
- Net change in post-bronchodilator FEV1
- symptom visual analogue score
- exhaled nitric oxide concentration
- computed alveolar nitric oxide concentration
- sputum differential inflammatory cell counts
- sputum supernatant mediator concentration.
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||September 2004|
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.
|Institute for Lung Health|
|Leicester, Leicestershire, United Kingdom, LE3 9QP|
|Principal Investigator:||Michael A Berry, MB, ChB||Institute for Lung Health|