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Evaluating Glycopyrronium for Children with Asthma

A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.

Phase 2 Interventional Novartis · NCT05222529

This study is testing if inhaled glycopyrronium can help children aged 6 to under 12 with asthma feel better while they continue their regular asthma medication.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment42 (estimated)
Ages6 Years to 11 Years
SexAll
SponsorNovartis Industry-sponsored
Locations23 sites (Rousse and 22 other locations)
Trial IDNCT05222529 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness, safety, and tolerability of two doses of inhaled glycopyrronium in children aged 6 to less than 12 years with asthma. It employs a double-blind, placebo-controlled, randomized design with multiple treatment periods and wash-out phases. Participants will receive either glycopyrronium bromide or a placebo while continuing their existing asthma medication. The outcomes will help determine the appropriate dose for future combination therapies.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to less than 12 years with a confirmed diagnosis of asthma and specific lung function criteria.

Not a fit: Patients who do not have a stable asthma condition or whose lung function does not meet the study criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved asthma management options for children, enhancing their quality of life.

How similar studies have performed: Other studies have shown promising results with similar inhaled therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Rousse and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaGlycopyrronium, pediatric, asthma, Breezhaler, PK
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.