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 in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
783
BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)
Oliver Kornmann - National Coordinator in Germany
Mainz, Germany
Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic
Time frame: 3 month period
Pre-dose FEV1
Time frame: every month
Post-dose FEV1 AUC 0-8 h
Time frame: 3 month period
FVC and FEF 25-75%
Time frame: every month
PEF
Time frame: every day
Morning and evening asthma clinical symptoms scores
Time frame: every day
Moderate and severe exacerbations
Time frame: every month
Rescue medication
Time frame: every day
Sputum
Time frame: 3 month period
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