A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 μg plus f...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002587-99

A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 μg plus formoterol 6 μg/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 μg/actuation), 4 puffs b.i.d., versus Seretide® 500/50 (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d., in patients with severe asthma

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

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