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Recruiting Phase 2 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

Phase 2 – studying effectiveness and dosage
Conditions: Asthma

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
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
Who can participate
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.
Interventions
GP MDI
COMBINATION_PRODUCT
BFF MDI
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Placebo MDI
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Locations 39
Argentina (12)
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Buenos Aires
NOT_YET_RECRUITING
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CABA
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La Plata
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Lanús Este
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Lobos
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Mar del Plata
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Mendoza
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Mendoza
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Rosario
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Rosario
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San Juan Bautista
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Santa Fe
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Czech Republic (2)
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Brno
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Prague
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Hungary (5)
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Debrecen
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Orosháza
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Szeged
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Székesfehérvár
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Szigetvár
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Mexico (3)
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Apodaca
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Guadalajara
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San Juan
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Poland (2)
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Lodz
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Tarnów
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Serbia (4)
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Belgrade
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Belgrade
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Belgrade
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Novi Sad
NOT_YET_RECRUITING
United States (11)
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Bakersfield , California
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Boston , Massachusetts
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Cincinnati , Ohio
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Columbia , Missouri
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Lafayette , Louisiana
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Long Beach , California
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Miami , Florida
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Oklahoma City , Oklahoma
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Owensboro , Kentucky
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Pembroke Pines , Florida
NOT_YET_RECRUITING
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San Diego , California
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Years
Maximum age
11 Years
Healthy volunteers
No
Start date
14.04.2026
Completion date
23.05.2029
Registry ID
NCT07525375
Source
clinicaltrials.gov
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