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

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Asthma

Treatments: Other: Non invasive measurement of airway inflammation

Study type: Interventional

Funder types: Other

Identifiers

NCT00262340

05/Q0404/30

Details and patient eligibility

About

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)

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

1

Experimental group

Description:

This arm will have treatment changed based on measures of inflammation

Treatment:

Other: Non invasive measurement of airway inflammation

2

Active Comparator group

Description:

Treatment will be changed on the basis of reported asthma symptoms

Treatment:

Other: Non invasive measurement of airway inflammation