The purpose of this study is to determine whether usind non-invasive measurements of airway inflammation can improve clinical decision making in children with severe asthma compared to conventional management (British Thoracic Society Guidelnes)

Condition	Intervention
Asthma	Procedure: Non invasive measurement of airay inflammation

Further study details as provided by Royal Brompton Hospital NHS Trust:

Primary Outcomes: 1. Asthma control assessed by:; (a)Number of exacerbations; (b) Number of symptom free days and bronchodialtor use per week; Both assessed over a 12 month period
Secondary Outcomes: (1)Doses of inhaled and oral corticosteroid used per year; (2)Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation
Expected Total Enrollment:  80

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   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Children >8 years with severe asyhma defined as:

Taking 500mcg fluticasone proprionate (or equivalent) per day, plus a long acting beta agonist plus a leukotriene antagonist or previous trial

Exclusion Criteria:

Children taking oral theophylline or cyclosporin Children with other major respiratory diagnoses such as bronchiectasis

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Please refer to this study by ClinicalTrials.gov identifier  NCT00262340

Andrew Bush, MB BS      0208    A.Bush@rbht.nhs.uk
Louise J Fleming, MB ChB      020 8352 8121  Ext. 2257    l.fleming@imperial.ac.uk

Study chairs or principal investigators

Andrew Bush, MBBS,  Principal Investigator,  Imperial College of Science Technology and Medicine, National Heart and Lung Institue   

Study ID Numbers:  05/Q0404/30
Last Updated:  December 8, 2005
Record first received:  December 5, 2005
ClinicalTrials.gov Identifier:  NCT00262340
Health Authority: United Kingdom: National Health Service
ClinicalTrials.gov processed this record on 2006-01-10