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

NCT ID: NCT00262340

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-02-29

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

This arm will have treatment changed based on measures of inflammation

Group Type: EXPERIMENTAL

Non invasive measurement of airway inflammation

Intervention Type: OTHER

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

2

Treatment will be changed on the basis of reported asthma symptoms

Group Type: ACTIVE_COMPARATOR

Non invasive measurement of airway inflammation

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart and Lung Institute

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

British Lung Foundation

OTHER

Sponsor Role: collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Bush, MBBS

Role: PRINCIPAL_INVESTIGATOR

Imperial College of Science Technology and Medicine, National Heart and Lung Institue

Locations

Royal Brompton Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

05/Q0404/30

Identifier Type: -

Identifier Source: org_study_id