Mobile

A 12-week, multinational, randomised, double blind, double dummy, 4-arm parallel-group study comparing the efficacy and safety of CHF 1535 (fixed combination of beclomethasone dipropionate + formotero...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-000401-11

A 12-week, multinational, randomised, double blind, double dummy, 4-arm parallel-group study comparing the efficacy and safety of CHF 1535 (fixed combination of beclomethasone dipropionate + formoterol fumarate) 100 + 6 μg/actuation inhalation powder, administered via the NEXT™ inhaler, versus CHF 1535 (fixed combination of beclomethasone dipropionate + formoterol fumarate) 100 + 6 μg/actuation, via HFA pressurised inhalation solution, in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Femme et Homme

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

Extrait

To demonstrate that CHF 1535 via NEXT™DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a “extrafine” pMDI in terms of pulmonary function (change from baseline in pre-dose morning FEV1) in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids (< 2000 µg BDP or equivalent).

Critère d'inclusion

  • Moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids (< 2000 µg BDP or equivalent)

Liens