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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

RecruitingPhase 2

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) Versus Placebo in Participants of 4 to Less Than 12 Years of Age With Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF)

Who can join

Ages 4 to 11 · All sexes

Full eligibility criteria
Main Inclusion Criteria:

* 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.

Main Exclusion Criteria:

* 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.

About the study

The purpose of this study is to evaluate the effect of 2 different GP metered dose inhaler (MDI) doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in participants 4 to less than 12 years of age with asthma.

What is being tested

Sponsor: AstraZeneca · Participants: 69 · Started: Apr 14, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07525375

Locations in the U.S.

CaliforniaResearch Site, Bakersfield
Research Site, Lancaster
Research Site, Long Beach
Research Site, San Diego (Not yet recruiting)
FloridaResearch Site, Miami
Research Site, Pembroke Pines
Research Site, Saint Cloud
KentuckyResearch Site, Owensboro
LouisianaResearch Site, Lafayette
MassachusettsResearch Site, Boston (Not yet recruiting)
MissouriResearch Site, Columbia
OhioResearch Site, Cincinnati (Not yet recruiting)
OklahomaResearch Site, Oklahoma City
TexasResearch Site, Lewisville
Research Site, San Antonio (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.