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

Prospective, Randomised Controlled Trial of the Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00262340
Enrollment
55
Registered
2005-12-06
Start date
2005-12-31
Completion date
2008-02-29
Last updated
2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Pediatrics, Airway, Inflammation

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.

Interventions

OTHERNon 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

Sponsors

National Heart and Lung Institute
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
British Lung Foundation
CollaboratorOTHER
Royal Brompton & Harefield NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
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 \-

Design outcomes

Primary

MeasureTime frame
Number of exacerbations;1 year
Number of symptom free days and bronchodilator use per week1 year

Secondary

MeasureTime frame
Doses of inhaled and oral corticosteroid used per year1 year
Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026