The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
October 28, 2015 updated by: Royal Brompton & Harefield NHS Foundation Trust
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW3 6NP
- Royal Brompton Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
Children taking steroid sparing agent (cyclosporin, azathioprine, methotrexate) Children with other major respiratory diagnoses such as bronchiectasis
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
This arm will have treatment changed based on measures of inflammation
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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
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Active Comparator: 2
Treatment will be changed on the basis of reported asthma symptoms
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of exacerbations;
Time Frame: 1 year
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1 year
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Number of symptom free days and bronchodilator use per week
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Doses of inhaled and oral corticosteroid used per year
Time Frame: 1 year
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1 year
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Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Bush, MBBS, Imperial College of Science Technology and Medicine, National Heart and Lung Institue
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
December 5, 2005
First Submitted That Met QC Criteria
December 5, 2005
First Posted (Estimate)
December 6, 2005
Study Record Updates
Last Update Posted (Estimate)
October 29, 2015
Last Update Submitted That Met QC Criteria
October 28, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/Q0404/30
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