RecruitingPhase 2NCT07525375

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)


Sponsor

AstraZeneca

Enrollment

69 participants

Start Date

Apr 14, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BFF MDI, GP MDI, and others for people with asthma. The study is currently recruiting participants at 39 locations. People eligible for this study include aged 4 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTGP MDI

GP MDI will be administered via oral inhalation twice daily (BID).

COMBINATION_PRODUCTBFF MDI

BFF MDI will be administered via oral inhalation BID.

COMBINATION_PRODUCTPlacebo MDI

Placebo MDI will be adminsitered via oral inhalation BID.


Locations(39)

Research Site

Bakersfield, California, United States

Research Site

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

Research Site

Belgrade, Serbia

Research Site

Belgrade, Serbia

Research Site

Novi Sad, Serbia

View Full Details on ClinicalTrials.gov

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NCT07525375


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