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Study details
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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

AstraZeneca
NCT IDNCT07433569ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Ages

4–12

Locations

6 sites in CA, FL, LA +2

What this study is about

This Phase 1 study is testing Budesonide in people with asthma. The primary outcome being measured is Maximum observed plasma concentration (Cmax).

Simplified from trial records by PatientMatch.

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
Standard assignment

Assignment is predetermined by the study protocol.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

budesonide, Respiratory System Agent (Adrenergic beta2-Agonists)

Drug routes

oral (Delayed Release Oral Capsule)

Endpoints

Primary: Maximum observed plasma concentration (Cmax)

Secondary: Apparent total body clearance (CL/F), Number of participants with adverse events, Terminal elimination half-life (t½λz), Time to reach peak or maximum observed concentration or response following drug administration (tmax)

Body systems

Respiratory