NCT00276029

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Dec 2003

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
Last Updated

May 4, 2006

Status Verified

September 1, 2004

First QC Date

January 10, 2006

Last Update Submit

May 3, 2006

Conditions

Asthma

Keywords

AsthmaRefractory

Outcome Measures

Primary Outcomes (2)

  • Methacholine PC20

  • Juniper asthma quality of life

Secondary Outcomes (8)

  • Net change in post-bronchodilator FEV1

  • FEF25-75

  • FVC

  • symptom visual analogue score

  • exhaled nitric oxide concentration

  • +3 more secondary outcomes

Interventions

EtanerceptDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic asthma Methacholine PC20\<8mg/ml

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Lung Health

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related 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. doi: 10.1056/NEJMoa050580.

    PMID: 16481637RESULT

MeSH Terms

Conditions

Asthma

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Michael A Berry, MB, ChB

    Institute for Lung Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

December 1, 2003

Study Completion

September 1, 2004

Last Updated

May 4, 2006

Record last verified: 2004-09

Locations

GB(1)