Study of Glycopyrronium Inhalation to Evaluate Safety, Effects, and Dosage in Children Ages 6 to Under 12 With Asthma

What this Trial Is About

The trial investigates the effects of two doses of inhaled glycopyrronium compared to placebo in children aged 6 to less than 12 years with moderate to severe asthma. The aim is to understand how glycopyrronium works in the body, its safety, and its impact on lung function. This information will guide the development of a combination asthma treatment including indacaterol, mometasone, and glycopyrronium for this age group. Participants will receive study treatments added to their regular asthma controller therapy, including salmeterol and fluticasone. The trial uses a double-blind, randomized crossover design where each child will receive glycopyrronium 12.5 g, glycopyrronium 25 g, and placebo in three separate two-week treatment periods. These periods are separated by two-week washout phases. The study includes four phases Screening, Run-in, Treatment, and Follow-up. During the study, lung function tests such as forced expiratory volume in one second FEV1 and peak expiratory flow PEF will be measured at the start and end of each treatment period. Pharmacokinetic blood samples will assess how the drug moves in the body. Safety will be monitored through adverse event tracking and electronic diaries completed by parents or guardians. The total participation time is approximately 20 weeks, including safety follow-up by phone 30 days after the last treatment.

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