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A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 ...

Update Il y a 4 ans
Reference: EUCTR2008-004842-10

A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT™ DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

Woman and Man

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Extract

To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT™ DPI (4 inhalations of beclomethasone dipropionate + formoterol fumarate, total dose: 400 + 24 µg) and CHF 1535 via HFA-134a “extrafine” pMDI (4 puffs of beclomethasone dipropionate + formoterol fumarate, total dose: 400 + 24 µg) and between a single dose of CHF 1535 via NEXT™ DPI (1 inhalation of beclomethasone dipropionate + formoterol fumarate, total dose: 100 + 6 µg) and CHF 1535 via HFA-134a “extrafine” pMDI (1 puff of beclomethasone dipropionate + formoterol fumarate, total dose: 100 + 6 µg) in partly controlled adult asthmatic patients.

Inclusion criteria

  • Partly controlled asthma in adult patients

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