The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: extrafine HFA-beclomethasone
* Drug: HFA-fluticasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 6.5 - 12 years 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: Instability of asthma during the past 3 months Presence of a disease that may intervene with the results of this study Active smoking Mental retardation Inability to perform the measurements properly

Ages Eligible for Study
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Minimum Age: 78 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: extrafine HFA-beclomethasone|nan|
|Drug: HFA-fluticasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| status of airway inflammation after a 3 months treatment period |  |  | 
| alveolar and bronchial exhaled nitric oxide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers in exhaled breath condensate |  |  | 
| lung function parameters |  |  | 
| symptoms / symptom free days |  |  | 
| adverse effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, non-invasive inflammometry, exhaled nitric oxide, exhaled breath condensate, paediatric, extrafine HFA-beclomethasone, HFA-fluticasone