This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
Pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the NEXT DPI dry powder inhaler or a free combination of Beclomethasone 100 ug DPI and Formoterol 6 ug DPI according to a cross-over design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).
four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)
BørneAstmaKlinikken, Hans Knudsens Plads 1A,
Copenhagen, Denmark
B17MP (active metabolite of BDP) Area Under Curve (AUC)
B17MP: Profile of Pharmacokinetics
Time frame: predose, 15,30min, 1,2,4,6,8 hours post dose
B17MP Cmax,Tmax,T1/2
BDP: profile of pharmacokinetics.
Time frame: predose, 15min,30min,1,2,4,6,8 hours post dose
BDP Area Under Curve (AUC), Cmax, Tmax, T1/2
BDP: profile of Pharmacokinetics
Time frame: predose, 15min,30min,1,2,4,6,8 hours postdose
Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2
Formoterol: profile of pharmacokinetics
Time frame: predose, 15min, 30 min, 1,2,4,6,8 hours postdose
plasma potassium Area Under Curve (AUC), Cmin, Tmin
plasma potassium to evaluate drug systemic effect
Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Heart Rate: Time averaged Heart Rate value: AUC0-t/t
Heart Rate to evaluate drug systemic effect
Time frame: predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose
Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).
Urinary cortisol to evaluate drug systemic effect
Time frame: from predose up to 8 hours postdose
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