Overview

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

Status:
Recruiting

Trial end date:
2022-04-04

Target enrollment:

Participant gender:

Summary

This is an open-label, two-period, single-sequence crossover study including 2 single dose treatments of mometasone furoate 100 μg administered via Twisthaler® and of 75/40 µg indacaterol acetate/mometasone furoate fixed dose combination 75/40 µg (QMF149) administered via Concept 1 device with a washout period between the two treatments. The study will include a screening period of up to 14 days, two single-dose treatments separated by a 4-7 day washout period (4 days is the minimum washout) and a 30-day investigational drug-free follow-up period.

Phase:

Phase 2

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Mometasone Furoate