The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry
NCT ID: NCT00402207
Last Updated: 2006-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2005-08-31
2006-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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extrafine HFA-beclomethasone
HFA-fluticasone
Eligibility Criteria
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Inclusion Criteria
* children with mild-persistent asthma
* treatment with inhaled corticosteroids(≤ 500 μg HFA-Flucticasone, ≤ 800 μg Budesonide, or ≤ 800 μg HFA-Beclometasone, daily)
* allowed, but needed to be used during the entire study period;
* short / long-acting β2-agonists
* leukotrien receptor antagonists
* antihistamines
Exclusion Criteria
* Presence of a disease that may intervene with the results of this study
* Active smoking
* Mental retardation
* Inability to perform the measurements properly
78 Months
12 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Teva Branded
INDUSTRY
Maastricht University Medical Center
OTHER
Principal Investigators
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Charlotte M Robroeks, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Rijn Jöbsis, MD, PhD
Role: STUDY_DIRECTOR
Maastricht University Medical Center
Edward Dompeling, MD, PhD
Role: STUDY_DIRECTOR
Maastricht University Medical Center
Locations
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University Hospital Maastricht
Maastricht, , Netherlands
Countries
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Other Identifiers
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MEC 05-005
Identifier Type: -
Identifier Source: org_study_id