RecruitingPhase 1NCT07433569

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


Sponsor

AstraZeneca

Enrollment

12 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how two common asthma medications — budesonide (a steroid) and formoterol (a bronchodilator) — are absorbed and processed by the body when delivered by different inhaler devices in children aged 4 to under 12 with asthma. **You may be eligible if...** - Your child is between 4 and under 12 years old - Your child has been diagnosed with asthma by a clinician for at least 3 months - Your child's weight is at least 15 kg and their BMI is at or below the 95th percentile for their age - Your child has been on a stable asthma treatment for at least 4 weeks **You may NOT be eligible if...** - Your child has a severe or unstable asthma condition - Your child has significant other health problems (heart, liver, or immune conditions) - Your child has recently had a chest infection or asthma attack - Your child is unable to use an inhaler correctly Talk to your doctor to see if this trial is right for you.

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_PRODUCTBudesonide/formoterol fumarate Aerosphere

Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.

COMBINATION_PRODUCTBudesonide/formoterol fumarate pMDI

Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.


Locations(6)

Research Site

Long Beach, California, United States

Research Site

Miami, Florida, United States

Research Site

Lafayette, Louisiana, United States

Research Site

Toledo, Ohio, United States

Research Site

Boerne, Texas, United States

Research Site

El Paso, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07433569


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