Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262340
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2005-12-05
Brief Title:
The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
Prospective Randomised Controlled Trial of the Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mcgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None