Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
NCT ID: NCT05222529
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
42 participants
INTERVENTIONAL
2022-08-29
2027-08-30
Brief Summary
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Detailed Description
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This study will consist of 4 phases: Screening, Run-in, Treatment and Follow-up.
After the screening phase, participants will enter the Run-in Phase to further assess eligibility and those participants that meet all eligibility criteria will be randomized. Study treatment will be administered in addition to background asthma LABA+ICS controller therapy (salmeterol xinafoate 50µg/fluticasone propionate 100µg) from entering the run-in period, through to the end of the treatment phase, including the 2 wash-out periods. Participants will be randomized to one of 6 different sequences with an equal (1:1:1:1:1:1) randomization ratio. The Treatment Phase will last 10 weeks, and every sequence is divided in three treatment periods: Glycopyrronium bromide 12.5 µg, Glycopyrronium bromide 25µg or matching placebo dry powder in capsules for inhalation, via Breezhaler. Each treatment period lasts 2 weeks and 2 consecutive treatment periods are separated by a 2-week wash-out period. Participants who discontinue their study treatment prematurely will be required to return to the clinic for an Early Termination Visit. 30 days after last treatment date, a final telephone contact must be conducted for safety follow-up.
The total duration of the trial for a participant (from screening to follow up) is approximately 20 weeks including safety follow-up.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Glycopyrronium 25μg
Glycopyrronium 25μg for two weeks
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
Glycopyrronium 12.5μg
Glycopyrronium 12.5μg for two weeks
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
Placebo
Placebo for two weeks
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
6 Years
11 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Rousse, , Bulgaria
Novartis Investigative Site
Sevlievo, , Bulgaria
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Ibagué, Tolima Department, Colombia
Novartis Investigative Site
Guatemala City, GTM, Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Eger, , Hungary
Novartis Investigative Site
Kaposvár, , Hungary
Novartis Investigative Site
Nagykanizsa, , Hungary
Novartis Investigative Site
Szigetvár, , Hungary
Novartis Investigative Site
Tarnów, , Poland
Novartis Investigative Site
Lodz, Łódź Voivodeship, Poland
Novartis Investigative Site
George, Western Cape, South Africa
Novartis Investigative Site
Cape Town, , South Africa
Novartis Investigative Site
Esplugues, Barcelona, Spain
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Mérida, Extremadura, Spain
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Stoke-on-Trent, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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2021-004972-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQVM149C2201
Identifier Type: -
Identifier Source: org_study_id
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