Femme et Homme
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Extrait
In symptomatic patients on high-doses ICS (Inhaled Corticosteroid) beclomethasone diproprionate (two puffs b.i.d.), to demonstrate the superiority of CHF 1535 200/6 (two puffs b.i.d.) versus a high dose of BDP (beclomethasone diproprionate 2000 μg/day) given as monotherapy, in terms of pulmonary function (change from baseline in pre-dose morning FEV1 measured at clinic) and asthma control (change from baseline in percentage of complete days without asthma symptoms), and the non-inferiority versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline in pre-dose morning FEV1 measured at clinic) during a 24-week treatment period.
Critère d'inclusion
- Patient with severe asthma