The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device. To determine lung exposure, the treatments are administered with charcoal block.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
One single day treatment of CHF 1535 100/6 NEXT DPI®: CHF 1535 dry powder for inhalation (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg per actuation) administered via the NEXT DPI® dry powder inhaler with charcoal block.
Medicines Evaluation Unit Ltd
Manchester, United Kingdom
lung bioavailability
To compare the lung bioavailability of B17MP (active metabolite of BDP) and formoterol after four inhalations using the new Chiesi dry powder inhaler vs pMDI using spacer device, with activated Charcoal Block.
Time frame: 13 times/24hr
To assess the safety and the tolerability of the study treatments considering AE and measuring vitals signs as blood pressure and heart rate in the specified time frame.
Adverse events and Vital signs: blood pressure and heart rate assessed at pre-dose and 30 min, 1, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose.
Time frame: 13 times/24hr
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