Femme et Homme
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Extrait
The primary objective of the study is to show that CHF 1535 50/6µg pMDI, 2 inhalations bid (total daily dose: BDP 200μg / FF 24μg) using AeroChamber Plus™ spacer device is non-inferior to a corresponding free combination of BDP 50μg pMDI, 2 inhalations bid (total daily dose: 200μg) plus FF 6μg pMDI, 2 inhalations bid (total daily dose: 24μg) using AeroChamber Plus™ spacer device in terms of lower leg growth rate (LLGR), measured by knemometry, over a 2-week treatment period
Critère d'inclusion
- Asthmatic children aged ≥ 5 and < 12 years