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

Inclusion Criteria:

• Confirmed diagnosis of asthma for at least 6 months

• Signed informed consent by parent(s)/legal guardian(s) and assent by the pediatricparticipant (depending on local requirements)

• Participant on stable dose of inhaled low-to-medium dose ICS with one additionalcontroller for at least 4 weeks prior to run-in

• Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in andrandomization. If FEV1 eligibility criteria are not met at -45min pre-dose of theEnd of Run-in (Visit 30), the visit can be rescheduled once within 5 days from theprevious attempt.

• FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase > and/or = 12% (performedaccording to American Thoracic Society (ATS)/European Respiratory Society (ERS) 2019guidelines). All participants must perform a reversibility test at start of Run-in.If reversibility is not demonstrated at Run-in, it may be attempted at up to two adhoc, unscheduled separate visits within 5 days from previous attempt. Ifreversibility is still not demonstrated after repeated assessment participants mustbe screen failed

• Demonstrated acceptable inhaler use technique for Diskus/Accuhaler (prior to run-in)and Breezhaler (prior to randomization) and able to complete spirometry proceduresprior to randomization.

• A parent/legal guardian must be designated to complete all e-Diary entries andattend all clinic visits with the participant.

• Parents/legal guardian must be willing and able to assist the child with theprocedures outlined in the protocol, e.g. compliance with study medication,completion of electronic participant diary

• Female participants of child-bearing potential, who might become sexually active,must be informed of the need to prevent pregnancy during the study using effectivecontraceptive methods. The decision on the contraceptive method should be reviewedat least every 3 months to evaluate the individual need and compatibility of themethod chosen.

Exclusion Criteria:

• Systemic corticosteroid use for any reason within 3 months of Run-in

• Participants on low to medium mono ICS alone

• Participants requiring six or more puffs of rescue medication per day on more thantwo consecutive days in the four weeks prior to Screening (Visit 1) and/or in thefour weeks prior to the Run-in visit

• Participants who have had an asthma attack/exacerbation requiring a) systemiccorticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3months prior to Screening (Visit 1), or more than 3 separate exacerbations in the 12months preceding the Screening visit

• Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outletobstruction or any other conditions where anticholinergic treatment iscontraindicated prior to Screening (Visit 1)

• Participants with a history of long QT syndrome or whose corrected QT interval (QTc)measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia method) is prolonged (> 450 msec for boys and girls) and confirmed by acentral assessor (these patients should not be rescreened)

• Suspected or documented active infections (bacterial, viral, fungal, mycobacterialor other, including active SARS-CoV-2, tuberculosis or atypical mycobacterialdisease) of the upper or lower respiratory tract, sinus or middle ear that is notresolved within 6 weeks of Screening (Visit 1)

• History of Type I diabetes or uncontrolled Type II diabetes

• Participants who are sexually active at screening

• Hemoglobin levels outside normal ranges at Run-in (Visit 20)

• Female patients of childbearing potential (e.g., are menstruating) who do not agreeto abstinence or, if they become sexually active during study participation, do notagree to the use of contraception as defined in the inclusion criteria.

Additional protocol-defined inclusion / exclusion criteria may apply.