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Sponsors and Collaborators: |
Royal Brompton Hospital NHS Trust National Heart and Lung Institute Imperial College London British Lung Foundation |
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Information provided by: | Royal Brompton Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00262340 |
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)
Condition | Intervention |
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Asthma |
Other: Non invasive measurement of airway inflammation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomised Controlled Trial of the Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma |
Estimated Enrollment: | 80 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | February 2008 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
This arm will have treatment changed based on measures of inflammation
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Other: Non invasive measurement of airway inflammation
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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2: Active Comparator
Treatment will be changed on the basis of reported asthma symptoms
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Other: Non invasive measurement of airway inflammation
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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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.
Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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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United Kingdom | |
Royal Brompton Hospital | |
London, United Kingdom, SW3 6NP |
Principal Investigator: | Andrew Bush, MBBS | Imperial College of Science Technology and Medicine, National Heart and Lung Institue |
Responsible Party: | Imperial college London ( Professor Andrew Bush ) |
Study ID Numbers: | 05/Q0404/30 |
Study First Received: | December 5, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00262340 |
Health Authority: | United Kingdom: National Health Service |
Asthma Pediatrics Airway Inflammation |
Nitric Oxide Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Inflammation |
Immune System Diseases Bronchial Diseases |