TNF Alpha in Refractory Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276029
• Other study ID #: etanercept/pr2
• Status: Completed
• Phase: N/A
• First received: January 10, 2006
• Last updated: May 3, 2006
• Start date: December 2003
• Est. completion date: September 2004

Study information

• Verified date: September 2004
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
United Kingdom	Institute for Lung Health	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Berry MA, Hargadon B, Shelley M, Parker D, Shaw DE, Green RH, Bradding P, Brightling CE, Wardlaw AJ, Pavord ID. Evidence of a role of tumor necrosis factor alpha in refractory asthma. N Engl J Med. 2006 Feb 16;354(7):697-708. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methacholine PC20
Primary	Juniper asthma quality of life
Secondary	Net change in post-bronchodilator FEV1
Secondary	FEF25-75
Secondary	FVC
Secondary	symptom visual analogue score
Secondary	exhaled nitric oxide concentration
Secondary	computed alveolar nitric oxide concentration
Secondary	sputum differential inflammatory cell counts
Secondary	sputum supernatant mediator concentration.