TNF Alpha in Refractory Asthma
- Conditions
- Asthma
- Registration Number
- NCT00276029
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- Symptomatic asthma Methacholine PC20<8mg/ml
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Juniper asthma quality of life Methacholine PC20
- Secondary Outcome Measures
Name Time Method Net change in post-bronchodilator FEV1 FVC exhaled nitric oxide concentration computed alveolar nitric oxide concentration symptom visual analogue score FEF25-75 sputum differential inflammatory cell counts sputum supernatant mediator concentration.
Trial Locations
- Locations (1)
Institute for Lung Health
🇬🇧Leicester, Leicestershire, United Kingdom