The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Four inhalations for a total dose of BDP/FF 200/24 mcg
Four inhalations for a total dose of BDP 200 mcg
Four inhalations for a total dose of Formoterol 24 mcg
BorneAstmaKlinikken
Copenhagen, Denmark
B17MP AUC0-t
B17MP (active metabolite of BDP) systemic exposure as AUC0-t
Time frame: pre-dose until 8hours post dose
B17MP PK profile
Time frame: pre-dose until 8 hours post-dose
BDP PK prolile
Time frame: Pre-dose until 8 hours post-dose
Formoterol PK profile
Time frame: Pre-dose until 8 hours post-dose
Plasma potassium AUC, Cmin, tmin
Plasma potassium to evaluate drug systemic effect
Time frame: Pre-dose until 8 hours post-dose
Urinary Cortisol excretion
8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects
Time frame: Pre-dose until 8 hours post-dose
Glucose in urine
Glucose to evaluate the drug systemic effects
Time frame: Pre-dose until 8 hours post-dose
Heart rate Time averaged heart rate value (AUC0-t)/t
Heart rate to evaluate the drug systemic effects
Time frame: Pre-dose until 8 hours post-dose
Spirometry: PEF
Peak respiratory flow as a measure of drug efficacy
Time frame: Pre-dose until 8 hours post-dose
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