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Efficacy and Safety of Inhaled Glycopyrronium Bromide Added to Budesonide and Formoterol Fumarate in Children 4‑12 Years with Asthma (Placebo‑Controlled)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on children aged 4 to less than 12 years who have Asthma. All participants already use an inhaled combination of budesonide and formoterol fumarate (known as BFF) to keep their breathing under control. The trial adds a new inhaled medicine, glycopyrronium bromide, at two different strengths and compares it with a dummy inhaler that contains no active drug.

The purpose of the study is to find out whether the added medicine improves lung function better than the dummy inhaler.

Each child will try the low dose, the high dose, and the dummy inhaler in a random order, while continuing their regular BFF inhaler. After each treatment period, lung function will be checked by measuring how much air can be forced out in one second (FEV1). The whole study lasts about three weeks for each treatment period.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit
You attend the first clinic visit after joining the study. during this visit lung function is measured and your health information is recorded. you receive the inhalers that will be used during the trial, including a background inhaler that contains bff (formoterol fumarate and budesonide) and a study inhaler that will contain either glycopyrronium bromide or a placebo.
Instructions on how to use the inhalers are explained, and a schedule for taking the medication is provided.
Step 2
Period 1 treatment
You start the first treatment period, which lasts three weeks. you inhale the assigned study inhaler (either a low dose of glycopyrronium bromide or a placebo) together with your regular bff inhaler.
The inhalers are used by pressing the device and breathing in, typically twice each day as directed by the study staff. you keep a diary to record each dose.
Step 3
End of period 1 assessment
After three weeks you return to the clinic for an assessment. lung function is measured again to see how your breathing has changed.
The inhalers used in period 1 are returned, and any unused medication is collected.
Step 4
Washout period
A short break of several days is taken to allow the medication from period 1 to leave your system before starting the next period.
Step 5
Period 2 treatment
You begin the second treatment period, also lasting three weeks. you now receive the other dose of glycopyrronium bromide if you previously took the low dose, or the low dose if you previously took the high dose, while continuing the regular bff inhaler.
The same dosing schedule is followed: inhalation twice daily for both the study inhaler and the background bff inhaler.
Step 6
End of period 2 assessment
At the end of the second three‑week period you attend another clinic visit. lung function is measured again and the inhalers from period 2 are returned.
Step 7
Washout period
Another short washout break is observed before the final treatment period.
Step 8
Period 3 treatment
You start the third and final treatment period, lasting three weeks. the inhaler you receive now contains the remaining option that has not yet been tested for you: either the placebo inhaler if you have already used both doses of glycopyrronium bromide, or the dose of glycopyrronium bromide that was not yet given.
You continue to use the background bff inhaler twice daily alongside the study inhaler.
Step 9
Final assessment and study completion
After the last three‑week period you return for the final clinic visit. lung function is measured for the last time, and all study materials are returned.
The information collected during the three periods is used to compare the effect of the two doses of glycopyrronium bromide and the placebo when added to bff.

Who can join the trial?

12 criteria

Child must be at least 4 years old but not yet 12 years old when the consent form is signed.
Parent or legal guardian must be willing and, in the investigator’s view, able to change the child’s asthma medicines as the study requires.
Child must be able to use a metered‑dose inhaler (MDI) with a spacer correctly, as judged by the investigator. (An MDI is a small inhaler that delivers a set dose of medicine; a spacer is a tube that helps the medicine get into the lungs more easily.)
Between the first two study visits, the child may only use the study inhaler (BFF MDI) twice daily and a rescue inhaler (albuterol/salbutamol) as needed; no other asthma medicines are allowed except those specifically permitted by the study.
Child must have a doctor‑diagnosed asthma for at least 12 weeks before the first visit, with medical records to confirm this.
Child must have been taking a stable dose of an inhaled corticosteroid (ICS) (equivalent to 160‑400 µg budesonide per day) plus one other asthma controller medication for at least 12 weeks, and the dose must have been unchanged for at least 1 month before the first visit.
Child must score 19 or higher on the Childhood Asthma Control Test at both the first and second visits. (This test measures how well asthma symptoms are being controlled.)
During a lung function test called spirometry, the child’s pre‑bronchodilator FEV1 (the amount of air exhaled in the first second) must be 95% or less of the predicted normal value at the screening visit and again at the randomization visit.
Child’s body‑mass index (BMI) must be at or below the 95th percentile for their age, and the child must weigh at least 14 kg.
Female participants who have started their periods (menarche) must have a negative urine pregnancy test at screening and must use effective birth control methods or abstain from sex during the study.
Child must give assent (agree) to join the study, and a parent or legal guardian who is 18 years or older must sign the informed consent form.
Parents or legal guardians must be willing and able to help the child follow all study procedures, including taking the study medication as directed.

Who cannot join the trial?

21 criteria

Cannot join if you had a life‑threatening asthma attack in the past year, such as needing a breathing tube (intubation), having very high carbon dioxide levels (hypercapnia), stopping breathing (respiratory arrest), having seizures caused by low oxygen (hypoxic seizures), or fainting because of asthma (syncopal episode).
Cannot join if you are allergic (known hypersensitivity) to any of the following medicine types: beta‑2‑agonists (bronchodilators that relax airway muscles), corticosteroids (anti‑inflammatory drugs), anticholinergics (medicines that help open airways), or any part of the inhaler device (MDI, which stands for metered‑dose inhaler).
Cannot join if you cannot stop using your short‑acting rescue inhalers or other asthma medicines for at least 6 hours before the lung function test (spirometry) that is required at each study visit.
Cannot join if you have taken any marketed biologic medicines (such as omalizumab, mepolizumab, benralizumab, or reslizumab) or any experimental biologic within the last 3 months or for a period equal to five times the drug’s half‑life (the time it takes for half of the drug to leave your body), whichever is longer, and you must not use them during the study.
Cannot join if you regularly use a nebulizer (a machine that turns liquid medicine into a mist you breathe) at home to receive asthma medicines.
Cannot join if you have used any immune‑system‑modifying drugs (immunomodulators or immunosuppressive medicines) within the last 3 months or for five half‑lives before screening, unless it is a short course of corticosteroids for an asthma flare‑up. Topical (skin‑applied) immune‑suppressing medicines may be allowed at the doctor’s discretion.
Cannot join if you cannot avoid taking medicines that are not allowed by the study protocol before and during the screening and treatment periods.
Cannot join if you have taken any experimental study drug or been in another clinical trial within the last 30 days or for five half‑lives before screening, whichever is longer.
Cannot join if your kidney function test (eGFR) is 60 mL/min/1.73 m² or lower, measured using the Schwartz formula, before the second visit.
Cannot join if you expect to be hospitalized for any reason during the study.
Cannot join if you are involved in planning or running the study, including being an employee of the sponsor (AstraZeneca) or the study site.
Cannot join if you have a current or past serious disease of any major organ system (heart, liver, kidneys, blood, nerves, hormones, stomach, or lungs) such as active tuberculosis, bronchiectasis (damage to the airways), or pulmonary eosinophilic syndromes, because it could make the study unsafe or affect the results.
Cannot join if the doctor believes you or your parent/guardian are unlikely to follow the study rules, visits, and requirements.
Cannot join if you have already taken part in this same study before.
Cannot join if a physical exam, blood test, urine test, vital signs, or heart test (ECG) shows abnormal results that the doctor thinks could put you at risk or affect the study, such as a prolonged QTcF interval (a measure of heart rhythm longer than 450 ms) or serious heart block (type II or III atrioventricular block) or problems with the heart’s natural pacemaker without having a pacemaker device.
Cannot join if you were hospitalized for asthma within 8 weeks before screening.
Cannot join if you have untreated narrow‑angle glaucoma (a type of eye pressure problem), recent changes in vision, bladder problems that affect urination, or any condition where anticholinergic medicines are not allowed, within 3 months before screening.
Cannot join if you used a long‑acting muscarinic antagonist (LAMA), either alone or in combination inhalers, in the 12 weeks before screening.
Cannot join if you are currently taking systemic beta‑blockers (medicines that affect the whole body and can worsen asthma), although eye drops for pressure control are allowed.
Cannot join if you had a respiratory infection that required antibiotics within 4 weeks before screening or during the screening/run‑in period.
Cannot join if you used systemic corticosteroids (steroid pills, injections, or depot shots) for any reason, including asthma attacks, within 4 weeks (or intramuscular/depot injections within 12 weeks) before screening or during the screening/run‑in period.

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Verified sites

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Fakultni Nemocnice U Sv Anny V Brne
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Brno-Stred, Czechia
Fakultni nemocnice Motol a Homolka
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Prague, Czechia
University Of Debrecen
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Debrecen, Hungary

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Investigated drugs

Glycopyrronium bromide
is an inhaled medicine that works by relaxing the muscles around the airways. By doing this, it helps keep the airways open so breathing becomes easier. In the study it is given through a pressurised inhaler and is added on top of the regular asthma inhaler that the children are already using.
Budesonide and Formoterol (BFF)
is a combined inhaler that contains two medicines. Budesonide is a steroid that reduces swelling and irritation inside the lungs, while formoterol is a long‑acting bronchodilator that quickly relaxes airway muscles to improve airflow. This combination is used as a regular (background) treatment for asthma, and the study looks at how adding glycopyrronium bromide to it affects lung function.

What is already known about the treatment

Glycopyrronium bromide
This drug is given as a pressurised inhalation suspension that is inhaled through a metered‑dose inhaler. Glycopyrronium bromide is an approved bronchodilator for chronic lung disease and is now being studied for use in children with asthma, appearing in current medical references. It works by blocking muscarinic receptors, which prevents the airway muscles from tightening and helps keep the airways open. It is classified as an anticholinergic (muscarinic antagonist) bronchodilator.
Formoterol fumarate / Budesonide
The combination is supplied as a pressurised inhalation suspension for use with a metered‑dose inhaler. Both ingredients are widely approved for asthma and are listed in standard medical literature as a regular maintenance inhaler. Formoterol rapidly relaxes airway muscles to widen the airways, while budesonide reduces inflammation in the lungs. Together they belong to the class of inhaled corticosteroid (ICS) and long‑acting β2‑agonist (LABA) combination therapies.

Investigated diseases

Asthma - Asthma is a chronic condition that affects the airways of the lungs, making them more sensitive and prone to narrowing. People with asthma experience episodes of wheezing, coughing, shortness of breath, and chest tightness, especially when exposed to triggers such as allergens, cold air, or exercise. During an episode, the muscles around the airways tighten and the lining swells, reducing airflow. Over time, repeated episodes can lead to a pattern of fluctuating symptoms that may become more frequent or severe. The condition often begins in childhood and can continue into later life, with symptom patterns that vary from person to person.