Asthma Clinical Trial
Official title:
Double Blind, Double Dummy, Cross-over Study to Compare the Bronchodilator Effect of CHF1535 pMDI (Fixed Combination of Beclometasone 50 µg + Formoterol 6 µg) Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children
The purpose of this clinical study is to compare the improvement in breathing of single
administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug
beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with
spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose
100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg)
given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.
Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to
placebo and the effect on other lung function parameters, to assess the safety and
tolerability of CHF 1535 dosages in children.
FEV1 from 0 to 12 hours standardised by time will be statistically analysed taking into account treatment, period and subject and pre-dose FEV1. ;
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