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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...

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Reference: 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

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Extract

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).

Inclusion criteria

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

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