Asthma Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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