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COMPAIRComparison of Budesonide and Formoterol Delivered With Symbicort Aerosphere® and Symbicort® pMDI in Children With Asthma

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Study Aim

This study aims to compare the systemic availability of budesonide and formoterol, after single doses of Symbicort Aerosphere and Symbicort pMDI, in children aged 4 to less than 12 years with asthma.

What is being tested

Budesonide/formoterol fumarate Aerosphere

+ Budesonide/formoterol fumarate pMDI

Combination Product
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

From 4 to 12 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 5, 2026

Actual date on which the first participant was enrolled.

This study is a phase 1 trial that aims to compare the effectiveness of two different inhalers, Symbicort Aerosphere® and Symbicort® pMDI, in children aged 4 to less than 12 years who have asthma. The inhalers contain the same medications, Budesonide and Formoterol, but they deliver the medicine in slightly different ways. The goal of this study is to understand which inhaler works better for children in this age group, helping to improve asthma treatment options for them. During the study, participants are randomly assigned to two groups. One group will use Symbicort Aerosphere® first, and the other group will use Symbicort® pMDI first. Each child will receive two puffs from their assigned inhaler. After a gap of 28 to 42 days, the groups will switch, and the children who first used Symbicort Aerosphere® will now use Symbicort® pMDI, and vice versa. The study measures how much of the medication reaches the bloodstream and how quickly it gets there. This helps to determine which inhaler is more effective at delivering the medication to the body.

Official TitlePhase 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
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

10 exclusion criteria prevent from participating
Prolonged QT interval corrected for heart rate using Fridericia's correction (QTcF)

Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma

History of life-threatening asthma defined as any asthma episode associated with loss of consciousness, intubation or admission to an intensive care unit

History of severe asthma exacerbation within 8 weeks of Visit 1

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will first receive a single dose of Budesonide/Formoterol Fumarate Aerosphere, followed by a single dose of Budesonide/Formoterol Fumarate pMDI. Both are inhaled treatments.

Group II

Experimental
In this group, participants will first receive a single dose of Budesonide/Formoterol fumarate pMDI (reference formulation). Later, they will receive a single dose of Budesonide/Formoterol fumarate Aerosphere (test formulation). Both are given as oral inhalations.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Research Site

Long Beach, United StatesOpen Research Site in Google Maps
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Research Site

Miami, United States
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Research Site

Lafayette, United States
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Research Site

Boerne, United States
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6 Study Centers