TNF Alpha in Refractory Asthma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276029

Enrollment

Registered

2006-01-12

Start date

2003-12-31

Completion date

2004-09-30

Last updated

2006-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Refractory

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.

Interventions

DRUGEtanercept

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Methacholine PC20	—
Juniper asthma quality of life	—

Secondary

Measure	Time frame
FVC	—
symptom visual analogue score	—
exhaled nitric oxide concentration	—
Net change in post-bronchodilator FEV1	—
sputum differential inflammatory cell counts	—
sputum supernatant mediator concentration.	—
computed alveolar nitric oxide concentration	—
FEF25-75	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026