Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ? 6 to < 12 Years Old With Asthma

Summary

Participation Requirements

Description

This is an open-label, two-period, single-sequence, crossover study to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Conce...

This is an open-label, two-period, single-sequence, crossover study to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Concept 1 (C1) device in ? 6 to <12 year old asthma patients. The study includes two open-label single-dose treatment visits. On the first treatment visit (Day 1) patients receive a single inhaled dose of 100 ?g MF administered via the Twisthaler® device. On the second treatment visit (Day 6) patients receive a single inhaled dose of 75/40 ?g indacaterol acetate/MF fixed dose combination (QMF149) via C1 device. Both treatments are in addition to their rescue medication and potentially standard of care asthma therapy (excluding MF and indacaterol acetate). The primary objective is to compare the systemic exposure to MF resulting from single doses of MF when administered as MF TH 100 ?g versus QMF149 75/40 ?g C1.

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