Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma

Study Summary

The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.

Conditions

Asthma

Interventions / Drugs

Glycopyrronium bromide 25ug Placebo Glycopyrronium bromide 12.5ug

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment42 participants

Primary Completion—

Lead SponsorNovartis Pharmaceuticals

Data Retrieved2026-04-11 02:55:49.152013+00:00

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