The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Non invasive measurement of airway inflammation

• Registration Number: NCT00262340
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief 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)

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-05
• Study First Submitted QC: 2005-12-05
• Study First Posted: 2005-12-06
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Non invasive measurement of airway inflammation	This arm will have treatment changed based on measures of inflammation
2	Non invasive measurement of airway inflammation	Treatment will be changed on the basis of reported asthma symptoms

Primary Outcome Measures

Name	Time	Method
Number of exacerbations;	1 year
Number of symptom free days and bronchodilator use per week	1 year

Secondary Outcome Measures

Name	Time	Method
Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation	1 year
Doses of inhaled and oral corticosteroid used per year	1 year

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom