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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262340
• Other study ID #: 05/Q0404/30
• Status: Completed
• Phase: N/A
• First received: December 5, 2005
• Last updated: October 28, 2015
• Start date: December 2005
• Est. completion date: February 2008

Study information

• Verified date: October 2015
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	British Lung Foundation, Imperial College London, National Heart and Lung Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbations;		1 year	No
Primary	Number of symptom free days and bronchodilator use per week		1 year	No
Secondary	Doses of inhaled and oral corticosteroid used per year		1 year	No
Secondary	Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation		1 year	No