The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
Copenhagen University Hospital
Copenhagen, Denmark
Medicines Evaluation Unit
Manchester, United Kingdom
Systemic exposure to B17MP (active metabolite of BDP) after single dose (4 inhalations) of CHF1535 100/6 NEXT DPI in comparison with an already approved free combination of BDP DPI and FF DPI
Plasma AUC0-t for B17MP
Time frame: 0-8hrs
Different pharmacokinetic parameters
BDP/B17MP and FF PK parameters
Time frame: 0-8hrs
Lung function parameters
Peak FEV1, FEV1 time averaged value (FEV1 AUC0-t/8).
Time frame: 0-8hrs
Plasma potassium
Plasma Potassium Cmin, tmin and AUC0-t
Time frame: 0-8hrs
Plasma glucose
Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t
Time frame: 0-8hrs
Heart rate
time averaged value (AUC0-t/8)
Time frame: 0-8hrs
Adverse Events
Time frame: during the whole study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.