TNF Alpha in Refractory Asthma

This study has been completed.
Sponsor:
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00276029
First received: January 10, 2006
Last updated: May 3, 2006
Last verified: September 2004
  Purpose

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


Condition Intervention
Asthma
Drug: Etanercept

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Methacholine PC20
  • Juniper asthma quality of life

Secondary Outcome Measures:
  • Net change in post-bronchodilator FEV1
  • FEF25-75
  • FVC
  • symptom visual analogue score
  • exhaled nitric oxide concentration
  • computed alveolar nitric oxide concentration
  • sputum differential inflammatory cell counts
  • sputum supernatant mediator concentration.

Estimated Enrollment: 10
Study Start Date: December 2003
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276029

Locations
United Kingdom
Institute for Lung Health
Leicester, Leicestershire, United Kingdom, LE3 9QP
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Principal Investigator: Michael A Berry, MB, ChB Institute for Lung Health
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00276029     History of Changes
Other Study ID Numbers: etanercept/pr2
Study First Received: January 10, 2006
Last Updated: May 3, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospitals, Leicester:
Asthma
Refractory

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014