Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
69
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
Pr DS SINGH
Manchester, United Kingdom
FEV1 AUC0-12h
Time frame: Every week
FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation
Time frame: Every week
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BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
Placebo