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

This study has been completed.
Sponsor:
Collaborators:
National Heart and Lung Institute
Imperial College London
British Lung Foundation
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00262340
First received: December 5, 2005
Last updated: October 28, 2015
Last verified: October 2015

December 5, 2005
October 28, 2015
December 2005
February 2008   (final data collection date for primary outcome measure)
  • Number of exacerbations; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of symptom free days and bronchodilator use per week [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 1. Asthma control assessed by:
  • (a)Number of exacerbations
  • (b) Number of symptom free days and bronchodialtor use per week
  • Both assessed over a 12 month period
Complete list of historical versions of study NCT00262340 on ClinicalTrials.gov Archive Site
  • Doses of inhaled and oral corticosteroid used per year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • (1)Doses of inhaled and oral corticosteroid used per year
  • (2)Comparison of daily versus single visit measures of eNO to predict an asthma exacerbation
Not Provided
Not Provided
 
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
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)
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Asthma
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
  • Experimental: 1
    This arm will have treatment changed based on measures of inflammation
    Intervention: Other: Non invasive measurement of airway inflammation
  • Active Comparator: 2
    Treatment will be changed on the basis of reported asthma symptoms
    Intervention: Other: Non invasive measurement of airway inflammation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
February 2008
February 2008   (final data collection date for primary outcome measure)

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

Both
8 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00262340
05/Q0404/30
No
Not Provided
Not Provided
Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
  • National Heart and Lung Institute
  • Imperial College London
  • British Lung Foundation
Principal Investigator: Andrew Bush, MBBS Imperial College of Science Technology and Medicine, National Heart and Lung Institue
Royal Brompton & Harefield NHS Foundation Trust
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP