Abstract
Rationale: To develop a new fixed formulation of Beclomethasone dipropionate (BDP) 50μg and Formoterol fumarate 6μg (CHF 1535 50/6) delivered via a pMDI for treatment of children with severe asthma.
Objective: To investigate pharmacokinetic of B17MP (active BDP metabolite) and Formoterol in children with asthma after inhalation of CHF 1535 50/6 vs. the licensed free combination of BDP and Formoterol dispensed with AeroChamber Plus™.
Methods: 22 children (5-11yrs) with mild asthma were included in this open-label, randomised, 2-way cross-over study of inhaled BDP 200μg and Formoterol 24μg. Eight-hour pharmacokinetic profiles (Cmax and AUC0-t) for B17MP and Formoterol after single inhalation were primary endpoints evaluated by analysis of variance and 90% bioequivalence limits.
Secondary endpoints were pharmacodynamics: serum potassium, heart rate, and cortisol excretion.
Results: B17MP and Formoterol pharmacokinetic parameters showed comparable values and the upper limit of the 90% CI was well within the bioequivalence limit. The pharmacodynamic parameters also showed similar values after both treatments.
Conclusion: After CHF 1535 50/6 administration, the BDP and Formoterol systemic exposure was similar to the systemic exposure of BDP and Formoterol administered as free combination supporting a comparable safety profile in children aged 5-11yrs.
- © 2011 ERS