Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Glycopyrronium bromide 25ug
25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Placebo
Placebo to Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Glycopyrronium bromide 12.5ug
12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler