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Phase II Study for Asthma in Children Aged 4 to 11

This study is for children aged 4 to 11 with asthma who are already using an inhaled corticosteroid and another asthma controller medication. It aims to see how two different doses of GP MDI (glycopyrronium metered dose inhaler), when added to BFF MDI (budesonide/formoterol fumarate metered dose inhaler), affect lung function compared to BFF MDI with a placebo. We're looking for changes in Forced Expiratory Volume in one second (FEV1), which measures how much air you can forcefully exhale in one second, after 3 weeks of treatment. You would need to have a doctor-diagnosed history of asthma, a Childhood Asthma Control Test score of 19 or higher, and a pre-bronchodilator FEV1 of 95% or less than the predicted normal value. The study plans to enroll 69 participants.

Study design
This is a Phase II, multi-center, randomized, double-blind study with 69 planned participants. You would be assigned to one of six treatment sequences, receiving different combinations of GP MDI, BFF MDI, and placebo MDI.
What's involved
The study involves a 3-week run-in period, followed by three 3-week treatment periods. You would take study medication via oral inhalation twice daily.
Compensation
Not stated in the trial record.
Follow-up
There will be a safety follow-up visit 12 to 16 days after your last dose of study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07525375

A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma

Recruiting
PHASE2Ages 4–11InterventionalTreatment
AstraZeneca
~69 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:GP MDIBFF MDIPlacebo MDI

At a glance

Recruiting sites
12 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT)
Measured over at 3 weeks

Conditions

Asthma

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Asthma

Where it's being run

43 sites across 15 states
Argentina12
Hungary5
California4
Serbia4
Florida3
Mexico3
Texas2
Czechia2

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

Participants who have a documented history of physician-diagnosed asthma
Participants who have been using a stable and regular inhaled corticosteroid plus one additional asthma controller medication.
Participants must have a Childhood Asthma Control Test score ≥ 19.
Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value.
Body mass index (BMI) ≤ 95 percentile for age and body weight of ≥ 14 kg or higher.
Female participants who experience menarche must have a negative urine pregnancy test.
Received no asthma medication other than run-in BFF MDI BID and albuterol/salbutamol as needed.

Exclusion

Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary.
Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG.
Hospitalization for asthma
Narrow-angle glaucoma not adequately treated and/or change in vision, bladder dysfunction, bladder outlet obstruction/urinary retention or any other conditions where anticholinergic treatment is contraindicated and may be relevant.
Use of Long-acting muscarinic antagonist (LAMA), either alone or as part of an inhaled combination therapy.
Current use of any systemic beta-blockers.
Respiratory infection involving antibiotic treatment.
Systemic corticosteroid use for any reason (including asthma exacerbations).
Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI.
Participants who are medically unable to withhold their short-acting bronchodilators and other asthma medications.
Any use of marketed (eg, omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic.
Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
Use of any immunomodulators or immunosuppressive medication.

What this trial measures

  • Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT)at 3 weeks

    Evaluate the effect of 2 different GP MDI doses relative to placebo MDI as an add-on treatment to BFF MDI on lung function in 4 to less than 12 years old participants with asthma.