At a glance
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The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
In Brief
A Phase 2 clinical trial evaluating Beclomethasone dipropionate HFA and placebo for Asthma and Bronchial Hyperresponsiveness. Completed, enrolled 21 participants across 1 site.
Detailed Summary
Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation. The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.
Study Details
Timeline
Interventions
100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test
inhalation twice a day for one month, preceded and followed by adenosine challenge test