COMPAIRComparison of Budesonide and Formoterol Delivered With Symbicort Aerosphere® and Symbicort® pMDI in Children With Asthma
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.
Budesonide/formoterol fumarate Aerosphere
+ Budesonide/formoterol fumarate pMDI
Asthma+6
+ Bronchial Diseases
+ Hypersensitivity
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
Research Site
Miami, United StatesResearch Site
Lafayette, United StatesResearch Site
Boerne, United States