AsthmaNCT00262340
The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
A study testing Non invasive measurement of airway inflammation in people with Asthma, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether using non-invasive measurements of airway inflammation can improve clinical decision making in children with severe asthma compared to conventional management (British Thoracic Society Guidelines) Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Non invasive measurement of airway inflammation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to Feb 2008
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children >8 years with severe asthma defined as:
- Taking at least 500mcg fluticasone propionate (or equivalent) per day, plus a long acting beta agonist plus a leukotriene antagonist or previous trial
Who cannot join
- Children taking steroid sparing agent (cyclosporin, azathioprine, methotrexate) Children with other major respiratory diagnoses such as bronchiectasis
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomised Controlled Trial of the Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
The purpose of this study is to determine whether using non-invasive measurements of airway inflammation can improve clinical decision making in children with severe asthma compared to conventional management (British Thoracic Society Guidelines)
Read the detailed description
Children with severe asthma pose a management dilemma; it is difficult to reduce their treatment while they are symptomatic, but the plateau of the dose response curve for inhaled corticosteroids (ICS) may have been reached. Studies in symptomatic adults and asymptomatic children with asthma suggest measuring induced sputum eosinophils allows better asthma management. We will recruit 80 children with severe asthma (treated with at least 500 mcg/day inhaled fluticasone or equivalent). We will see them every three months for a year, and perform sputum induction and measurements of exhaled nitric oxide (eNO). Half will be randomised to conventional management; half will have a reduction of ICS if there are no sputum eosinophils, or (if a sample cannot be produced) eNO is normal. The trial endpoint is whether there is a significant reduction in the median dose of ICS in the inflammatory markers group, with no increase in total number of asthma exacerbations. This study is also hypothesis generating. We will use our panel of markers (a) to try to improve clinical monitoring; and (b) to determine the molecular mechanisms of relapse of severe asthma.
- Conditions
- Asthma
- Being tested
- Non invasive measurement of airway inflammation
- Keywords
- Asthma, Pediatrics, Airway, Inflammation
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive measurement of airway inflammationOther
Airway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This arm will have treatment changed based on measures of inflammation Receives: Other: Non invasive measurement of airway inflammation |
| 2 | Active comparator | Treatment will be changed on the basis of reported asthma symptoms Receives: Other: Non invasive measurement of airway inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations;
Measured: 1 year
Number of symptom free days and bronchodilator use per week
Measured: 1 year
Secondary outcomes (2)
Doses of inhaled and oral corticosteroid used per year
Measured: 1 year
Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart and Lung Institute, Imperial College London, British Lung Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew Bush, MBBS, Principal investigator, Imperial College of Science Technology and Medicine, National Heart and Lung Institue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262340
- Sponsor's protocol ID
- 05/Q0404/30
- Status last verified
- Oct 2015
- First submitted
- 5 Dec 2005
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised Controlled Trial of the Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
- ClinicalTrials.gov ID
- NCT00262340
- Acronym / sponsor ID
- 05/Q0404/30
- Conditions
- Asthma
- Keywords
- Asthma, Pediatrics, Airway, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Heart and Lung Institute, Imperial College London, British Lung Foundation
- Study start
- Dec 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Dec 2005 (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 is to determine whether using non-invasive measurements of airway inflammation can improve clinical decision making in children with severe asthma compared to conventional management (British Thoracic Society Guidelines)
Detailed description
Children with severe asthma pose a management dilemma; it is difficult to reduce their treatment while they are symptomatic, but the plateau of the dose response curve for inhaled corticosteroids (ICS) may have been reached. Studies in symptomatic adults and asymptomatic children with asthma suggest measuring induced sputum eosinophils allows better asthma management. We will recruit 80 children with severe asthma (treated with at least 500 mcg/day inhaled fluticasone or equivalent). We will see them every three months for a year, and perform sputum induction and measurements of exhaled nitric oxide (eNO). Half will be randomised to conventional management; half will have a reduction of ICS if there are no sputum eosinophils, or (if a sample cannot be produced) eNO is normal. The trial endpoint is whether there is a significant reduction in the median dose of ICS in the inflammatory markers group, with no increase in total number of asthma exacerbations. This study is also hypothesis generating. We will use our panel of markers (a) to try to improve clinical monitoring; and (b) to determine the molecular mechanisms of relapse of severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Non invasive measurement of airway inflammationThis arm will have treatment changed based on measures of inflammation |
| 2 | Active comparator | Other: Non invasive measurement of airway inflammationTreatment will be changed on the basis of reported asthma symptoms |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Taking at least 500mcg fluticasone propionate (or equivalent) per day, plus a long acting beta agonist plus a leukotriene antagonist or previous trial
Key exclusion criteria (2 listed)
- Children taking steroid sparing agent (cyclosporin, azathioprine, methotrexate) Children with other major respiratory diagnoses such as bronchiectasis
- -
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 |
|---|---|---|
| Non invasive measurement of airway inflammationAirway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management | Other | 1, 2 |
Primary outcome
Number of exacerbations;
Time frame: 1 year
Number of symptom free days and bronchodilator use per week
Time frame: 1 year
2 secondary outcomes
Doses of inhaled and oral corticosteroid used per year
Time frame: 1 year
Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation
Time frame: 1 year
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 29 Oct 2015.
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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.
Andrew Bush, MBBS principal investigator
Imperial College of Science Technology and Medicine, National Heart and Lung Institue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive measurement of airway inflammation in people with Asthma, run by Royal Brompton & Harefield NHS Foundation Trust 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 2 inclusion and 2 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 29 Oct 2015. 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?
Number of exacerbations; (time frame: 1 year). 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?
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 29 Oct 2015.