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Looking for participantsPhase2

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

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT05222529

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Glycopyrronium bromide 25ug (drug), Placebo (drug), Glycopyrronium bromide 12.5ug (drug)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Glycopyrronium bromide 25ug — drug: 25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler · Placebo — drug: Placebo to Glycopyrronium bromide capsules for oral inhalation via Breezhaler · Glycopyrronium bromide 12.5ug — drug: 12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Patient visit burden
Not specified by the sponsor

In plain English

This study looked at how the medicine glycopyrronium (bromide) moves through and affects the body, and how safe and well tolerated it is, in children aged 6 to under 12 who have asthma. It was run by Novartis Pharmaceuticals.

Who can take part

  • Asthma diagnosed at least 6 months ago
  • Parent or legal guardian gives consent, and the child agrees where required
  • Already taking a stable dose of a low-to-medium dose inhaled corticosteroid (ICS) plus one other controller medicine for at least 4 weeks before the run-in period
  • Breathing test (FEV1) results between 60% and 90% of the predicted normal value at set points in the study
  • Breathing improves by at least 12% after using a reliever inhaler (up to 4 puffs of salbutamol or albuterol) in a reversibility test
  • Able to use the study inhaler devices (Diskus/Accuhaler and Breezhaler) correctly and complete breathing tests
  • A parent or legal guardian must attend all clinic visits and complete the electronic diary with the child
  • Girls who could become pregnant and might become sexually active must use effective contraception during the study

Who may not be able to

  • Use of corticosteroid tablets or injections for any reason in the 3 months before the run-in period
  • Taking a low-to-medium dose inhaled corticosteroid (ICS) alone with no other controller medicine
  • Needing six or more puffs of reliever medicine per day on more than two days in a row in the 4 weeks before screening or run-in
  • An asthma attack needing steroid tablets, a hospital stay, or an emergency room visit within 3 months of screening, or more than 3 separate attacks in the past 12 months
  • Narrow-angle glaucoma, bladder problems, or other conditions where anticholinergic medicines should not be used
  • A history of long QT syndrome (a heart rhythm problem) or a prolonged QT interval on a heart test
  • An infection of the airways, sinuses, or ear that had not cleared up within 6 weeks of screening
  • Type 1 diabetes, or uncontrolled Type 2 diabetes
  • Being sexually active at screening
  • Haemoglobin (a blood measure) outside the normal range at the run-in visit
  • Girls who have started their periods who do not agree to avoid sex or use contraception during the study

What taking part involves

  • • The study medicine is glycopyrronium (bromide), an inhaled anticholinergic medicine taken using a Breezhaler inhaler device
  • • Details of the study treatment plan (for example, doses, length of treatment, and whether there is a placebo group) are not stated — ask the trial team

Time commitment: Not fully stated — ask the trial team about the total number of visits and study duration; taking part involves clinic visits with a parent or guardian, breathing tests, and completing an electronic diary.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
6 Years to 11 Years
Who
All
Number of participants
42
Started
2022-08-29
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for asthma
  • • Phase2 - 42 participants
  • • 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

Who can take part?

  • • Ages 6 Years to 11 Years
  • • Diagnosed with asthma

Where?

  • • London - Novartis Investigative Site
  • • Stoke-on-Trent - Novartis Investigative Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The study design is a double-blind, placebo controlled, randomized sequence, three-treatment, three-period, six-sequence, cross-over multiple-dose study to evaluate efficacy, pharmacokinetics, pharmacodynamics, and safety and tolerability of glycopyrronium bromide (bromide) in children from 6 to less than 12 years of age with asthma with forced expiratory volume in one second (FEV1) ≥60% and ≤ 90% of the predicted normal value for the participant. 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.

Asthma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Years - 11 Years
  • Who can join: All genders

Biomarkers mentioned

met

What the study is looking for

  • ✓Confirmed diagnosis of asthma for at least 6 months
  • ✓Signed agreement to take part by parent(s)/legal guardian(s) and assent by the pediatric participant (depending on local...
  • ✓Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks...
  • ✓Demonstrated acceptable inhaler use technique for Diskus/Accuhaler (prior to run-in) and Breezhaler (prior to...
  • ✓A parent/legal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the...

Who cannot take part

  • ✗Systemic corticosteroid use for any reason within 3 months of Run-in
  • ✗Participants on low to medium mono ICS alone
  • ✗Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other...
  • ✗History of Type I diabetes or uncontrolled Type II diabetes
  • ✗Participants who are sexually active at screening
See the full 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 Is This Study? (2 UK sites)

Novartis Investigative Site

London SE5 9RS, United Kingdom

Recruiting

Novartis Investigative Site

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-08