AsthmaNCT00276029
TNF Alpha in Refractory Asthma
A study testing Etanercept in people with Asthma, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Etanercept
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2003to Sep 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic asthma Methacholine PC20<8mg/ml
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute for Lung Health
Leicester, Leicestershire, LE3 9QP
About this study
Official title: The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study
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
Read the 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.
- Conditions
- Asthma
- Being tested
- Etanercept
- Keywords
- Asthma, Refractory
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
computed alveolar nitric oxide concentration
sputum differential inflammatory cell counts
sputum supernatant mediator concentration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startDec 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Investigators
- Michael A Berry, MB, ChB, Principal investigator, Institute for Lung Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276029
- Sponsor's protocol ID
- etanercept/pr2
- Status last verified
- Sep 2004
- First submitted
- 10 Jan 2006
- Last updated
- 4 May 2006
- Results posted
- No
Publications
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.
PubMed 16481637
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00276029
- Acronym / sponsor ID
- etanercept/pr2
- Conditions
- Asthma
- Keywords
- Asthma, Refractory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Sep 2004
- First posted
- 12 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic asthma Methacholine PC20<8mg/ml
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etanercept | Drug | – |
Primary outcome
Methacholine PC20
Juniper asthma quality of life
8 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2006.
- Results publication: PubMed 16481637Berry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Berry, MB, ChB principal investigator
Institute for Lung Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etanercept in people with Asthma, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methacholine PC20. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2006.