This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products; this will be additionally compared to the systemic exposure in adults without the spacer device.
The proposed clinical pharmacology study is aimed to investigate the systemic availability of BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI (to reach a total dose of BDP 400 µg and formoterol 24 µg) with and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus formoterol pMDI licensed products (to reach the same total dose of BDP and formoterol) in adolescent asthmatic patients. The systemic exposure to BDP/B17MP and formoterol after inhalation of CHF 1535 pMDI in adolescents will be additionally compared to the systemic exposure in adults without the spacer device. The chosen doses correspond to the maximum daily dose of the two components administered as fixed combination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Uniwersytecki Szpital Kliniczny nr 1
Lodz, Poland
AUC0-t of B17MP CHF 1535 100/6 pMDI with and without spacer vs free combination of BDP pMDI and formoterol pMDI
In adolescents, the systemic exposure of B17MP as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) vs already licensed free combination of BDP pMDI and formoterol pMDI without spacer.
Time frame: : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.
AUC0-t, AUC0-inf, Cmax, tmax and t½ for BDP and formoterol
In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.
Time frame: : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.
AUC0-0.5h, AUC0-inf, Cmax, tmax and t½ for B17MP
In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.
Time frame: : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.
plasma glucose and plasma potassium AUC0-t; Cmin; Tmin; Cmax; Tmax
In adolescents, after inhalation of CHF 1535 100/6 pMDI with and without spacer (AeroChamber Plus™)vs fre combination
Time frame: : pre-dose (within 5 min from dosing), 5 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.
Heart rate as AUC0-8h of CHF 1535 100/6 pMDI
In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs free combination
Time frame: pre-dose (within 5 min from dosing), 5 min; 10 min; 15 min; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.
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FEV1; time everaged FEV1 value AUC0-8h; peak FEV1
In adolescents, after inhalation of CHF1535 100/6 pMDI both with and without spacer vs a free combination of licensed BDP and Formoterol pMDIs.
Time frame: pre-dose; 30 min; 1, 2, 4, 6 and 8 hr after inhalation.