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.
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.
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
Crossover
Glycopyrronium bromide 25ug
Drug25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Placebo
DrugPlacebo to Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Glycopyrronium bromide 12.5ug
Drug12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Change from Baseline in trough FEV1
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
Steady state pharmacokinetic (PK) parameters C0
Steady state pharmacokinetic (PK) parameters C0 will be provided for plasma glycopyrronium concentrations at pre-dose and post-dose time-points.
Systemic exposure following sparse PK sampling
Systemic exposure following sparse PK sampling will be provided at pre-dose and post-dose time-points for each glycopyrronium dose level
Change from Baseline in PEF rate
Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration.
Change from Baseline in FEV1
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
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