NCT07433569

A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma

Phase I Study to Compare the Pharmacokinetics of Budesonide and Formoterol Delivered With Symbicort Aerosphere® and Symbicort® pMDI in Children 4 to Less Than 12 Years of Age With Asthma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.

Detailed description

This is a phase I single-dose, 2-period cross-over, multicenter study in which the participants will be randomized 1:1 to one of two treatment sequences - AB or BA. In the first study period, participants will receive a single dose of either - 1. Treatment A: Symbicort Aerosphere budesonide/formoterol fumarate × 2 puffs (test formulation) 2. Treatment B: Symbicort pMDI budesonide/formoterol fumarate × 2 puffs (reference formulation) After a washout period of at least 28 days and no longer than 42 days, participants who first received Treatment A will receive a single dose of Treatment B, and participants who first received Treatment B will receive a single dose of Treatment A in the study period 2.

Conditions

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Budesonide/formoterol fumarate Aerosphere	Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.
COMBINATION_PRODUCT	Budesonide/formoterol fumarate pMDI	Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.

Timeline

• Start date: 2026-03-05
• Primary completion: 2026-10-22
• Completion: 2026-10-22
• First posted: 2026-02-25
• Last updated: 2026-03-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study