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New asthma inhaler trial for kids: could improve breathing

NCT ID NCT05222529

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This study tests two doses of an inhaled drug called glycopyrronium in 42 children aged 6 to 12 with moderate to severe asthma. The goal is to see how well it opens airways and how safe it is compared to a placebo. Results will help decide the best dose for future combination treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Glycopyrronium bromide (an inhaled bronchodilator)
What this could lead to
If successful, this could help determine the right dose of glycopyrronium for children with asthma, potentially leading to a new combination inhaler that improves breathing control.
What could go wrong
This is an early Phase 2 trial with only 42 children, so results may not apply to all. The drug is already used in adults, but its effectiveness and safety in children are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Rousse, 7002, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Sevlievo, 5400, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Sofia, 1510, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Ibague, Tolima Department, 730006, Colombia

  • Novartis Investigative Site

    WITHDRAWN

    Guatemala City, GTM, 01010, Guatemala

  • Novartis Investigative Site

    RECRUITING

    Guatemala City, 01015, Guatemala

  • Novartis Investigative Site

    RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1033, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    RECRUITING

    Eger, 3300, Hungary

  • Novartis Investigative Site

    WITHDRAWN

    Kaposvár, 7400, Hungary

  • Novartis Investigative Site

    WITHDRAWN

    Nagykanizsa, 8800, Hungary

  • Novartis Investigative Site

    RECRUITING

    Szigetvár, 7900, Hungary

  • Novartis Investigative Site

    RECRUITING

    Tarnów, Poland, 33-100, Poland

  • Novartis Investigative Site

    RECRUITING

    Lodz, Łódź Voivodeship, 90-329, Poland

  • Novartis Investigative Site

    RECRUITING

    George, Western Cape, 6529, South Africa

  • Novartis Investigative Site

    RECRUITING

    Cape Town, 7531, South Africa

  • Novartis Investigative Site

    RECRUITING

    Esplugues, Barcelona, 08950, Spain

  • Novartis Investigative Site

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Mérida, Extremadura, 06800, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

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