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 pediatric
participant (depending on local requirements)

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

- Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and
randomization. If FEV1 eligibility criteria are not met at -45min pre-dose of the
End of Run-in (Visit 30), the visit can be rescheduled once within 5 days from the
previous 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% (performed
according to American Thoracic Society (ATS)/European Respiratory Society (ERS) 2019
guidelines). 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 ad
hoc, unscheduled separate visits within 5 days from previous attempt. If
reversibility is still not demonstrated after repeated assessment participants must
be screen failed

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

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

- Parents/legal guardian must be willing and able to assist the child with the
procedures 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 effective
contraceptive methods. The decision on the contraceptive method should be reviewed
at least every 3 months to evaluate the individual need and compatibility of the
method 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 than
two consecutive days in the four weeks prior to Screening (Visit 1) and/or in the
four weeks prior to the Run-in visit

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

- Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet
obstruction or any other conditions where anticholinergic treatment is
contraindicated 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 a
central assessor (these patients should not be rescreened)

- Suspected or documented active infections (bacterial, viral, fungal, mycobacterial
or other, including active SARS-CoV-2, tuberculosis or atypical mycobacterial
disease) of the upper or lower respiratory tract, sinus or middle ear that is not
resolved 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 agree
to abstinence or, if they become sexually active during study participation, do not
agree to the use of contraception as defined in the inclusion criteria.

Additional protocol-defined inclusion / exclusion criteria may apply.