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
Start Date
4/14/2026
Completion Date
5/23/2029
Summary
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.
Detailed 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
Eligibility Criteria
Age Range: 4 years to 11 years
Interventions
GP MDI
BFF MDI
Placebo MDI
Conditions
Locations
Research Site
Bakersfield, California 93301
United States
Research Site
Long Beach, California 90806
United States
Research Site
San Diego, California 92123
United States
Research Site
Miami, Florida 33125
United States
Research Site
Pembroke Pines, Florida 33026
United States
Research Site
Owensboro, Kentucky 42301
United States
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Lafayette, Louisiana 70508
United States
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Boston, Massachusetts 02114
United States
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Columbia, Missouri 65203
United States
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Cincinnati, Ohio 45229
United States
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Oklahoma City, Oklahoma 73120
United States
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Buenos Aires, C1122
Argentina
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CABA, 1426
Argentina
Research Site
La Plata, B1900AXI
Argentina
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Lanús Este, B1824KAJ
Argentina
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Lobos, 7240
Argentina
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Mar del Plata, B7600
Argentina
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Mendoza, 5500
Argentina
Research Site
Mendoza, M5500
Argentina
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Rosario, 2000
Argentina
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Rosario, S2000CVD
Argentina
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San Juan Bautista, 1888
Argentina
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Santa Fe, 3000
Argentina
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Brno, 65691
Czechia
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Prague, 15006
Czechia
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Debrecen, 4032
Hungary
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Orosháza, 5900
Hungary
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Szeged, 6720
Hungary
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Székesfehérvár, 8000
Hungary
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Szigetvár, 7900
Hungary
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Apodaca, 64620
Mexico
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Guadalajara, 44130
Mexico
Research Site
San Juan, 00909
Mexico
Research Site
Lodz, 90-329
Poland
Research Site
Tarnów, 33-100
Poland
Research Site
Belgrade, 11000
Serbia
Research Site
Belgrade, 11040
Serbia
Research Site
Belgrade, 11070
Serbia
Research Site
Novi Sad, 21000
Serbia