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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	GP MDI	GP MDI will be administered via oral inhalation twice daily (BID).
COMBINATION_PRODUCT	BFF MDI	BFF MDI will be administered via oral inhalation BID.
COMBINATION_PRODUCT	Placebo MDI	Placebo MDI will be adminsitered via oral inhalation BID.

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-05-23
• Completion: 2029-05-23
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

39 sites across 7 countries: United States, Argentina, Czechia, Hungary, Mexico, Poland, Serbia

Regulatory

• FDA-regulated drug study