Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402207
Status:
COMPLETED
Last Update Posted:
2006-11-22
First Post:
2006-11-20
Brief Title:
The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone by Means of Inflammometry
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone by Means of Exhaled Nitric Oxide Inflammatory Markers in Exhaled Breath Condensate and Conventional Parameters
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Background Chronic inflammation in peripheral airways plays an important role in the pathophysiology of asthma Extrafine hydrofluoroalkane HFA beclometasone is distinguished from other ICS because of its fine aerosol characteristics As a result there is a greater extent of deposition of extrafine HFA-beclometasone in the peripheral airways Therefore extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with asthma
Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide NO concentration and bronchial NO flux inflammatory markers in exhaled breath condensate EBC and conventional parameters
Method In a cross-over study design of 6 months 33 children aged 6-12 years with doctor diagnosed mild persistent asthma were treated with extrafine HFA-beclometasone inhaled from an autohaler and HFA-flucticasone inhaled from a discus Primary outcome parameters of this study were alveolar NO concentration and bronchial NO flux Secondary outcome parameters were inflammatory markers in EBC lung function parameters symptoms presence and duration of exacerbations and adverse effects All parameters were recorded at baseline and after each treatment period
Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide NO concentration and bronchial NO flux inflammatory markers in exhaled breath condensate EBC and conventional parameters
Method In a cross-over study design of 6 months 33 children aged 6-12 years with doctor diagnosed mild persistent asthma were treated with extrafine HFA-beclometasone inhaled from an autohaler and HFA-flucticasone inhaled from a discus Primary outcome parameters of this study were alveolar NO concentration and bronchial NO flux Secondary outcome parameters were inflammatory markers in EBC lung function parameters symptoms presence and duration of exacerbations and adverse effects All parameters were recorded at baseline and after each treatment period
Detailed Description:
None
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