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Completed

NCT Number: NCT00276029

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Lung Health

Leicester, Leicestershire, LE3 9QP, United Kingdom

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. Methacholine PC20

  2. Juniper asthma quality of life

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Jan 12, 2006
Registry last updated
May 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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