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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

NCT07525375 · AstraZeneca
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Official title
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)
About this study
This is a Phase II, multi-center, randomized, double-blind, 3-period, 6-sequence crossover study evaluating two doses of GP Metered-Dose Inhaler (MDI) compared with placebo MDI as add-on therapy to BFF MDI. The study comprises a 3-week run-in period, followed by three 3-week treatment periods where participants will be randomized to one of six treatment sequences, and a safety follow-up visit 12 to 16 days after the last dose of study intervention. The treatment periods are as follows: * Treatment A: BFF MDI + GP MDI Dose A * Treatment B: BFF MDI + GP MDI Dose B * Treatment C: BFF MDI + Placebo MDI
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.
Study design
Enrollment target: 69 participants
Allocation: randomized
Masking: triple
Age groups: child
Timeline
Starts: 2026-04-14
Estimated completion: 2029-05-23
Last updated: 2026-04-22
Interventions
Combination Product: GP MDICombination Product: BFF MDICombination Product: Placebo MDI
Primary outcomes
  • 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)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (39)
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Bakersfield, California, United States
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Long Beach, California, United States
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San Diego, California, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Owensboro, Kentucky, United States
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Lafayette, Louisiana, United States
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Boston, Massachusetts, United States
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Columbia, Missouri, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Buenos Aires, Argentina
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CABA, Argentina
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La Plata, Argentina
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Lanús Este, Argentina
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Lobos, Argentina
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Mar del Plata, Argentina
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Mendoza, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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Rosario, Argentina
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San Juan Bautista, Argentina
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Santa Fe, Argentina
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Brno, Czechia
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Prague, Czechia
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Debrecen, Hungary
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Orosháza, Hungary
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Szeged, Hungary
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Székesfehérvár, Hungary
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Szigetvár, Hungary
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Apodaca, Mexico
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Guadalajara, Mexico
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San Juan, Mexico
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Lodz, Poland
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Tarnów, Poland
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Belgrade, Serbia
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Belgrade, Serbia
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Belgrade, Serbia
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Novi Sad, Serbia
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 · TrialPath