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
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
- GP MDI (combination product)
- BFF MDI (combination product)
- Placebo MDI (combination product)
Sponsor: AstraZeneca · Participants: 69 · Started: Apr 14, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07525375
Locations in the U.S.
| California | Research Site, Bakersfield Research Site, Lancaster Research Site, Long Beach Research Site, San Diego (Not yet recruiting) |
| Florida | Research Site, Miami Research Site, Pembroke Pines Research Site, Saint Cloud |
| Kentucky | Research Site, Owensboro |
| Louisiana | Research Site, Lafayette |
| Massachusetts | Research Site, Boston (Not yet recruiting) |
| Missouri | Research Site, Columbia |
| Ohio | Research Site, Cincinnati (Not yet recruiting) |
| Oklahoma | Research Site, Oklahoma City |
| Texas | Research 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.