Comparing how two inhalers deliver budesonide/formoterol in children 4 to under 12 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
This trial will test whether a single dose of Symbicort Aerosphere or Symbicort pMDI is absorbed differently and is safe in children aged 4 to under 12 who have asthma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 6 sites (Long Beach, California and 5 other locations) |
| Trial ID | NCT07433569 on ClinicalTrials.gov |
What this trial studies
This is a phase I, single-dose, two-period crossover study in children aged 4 to less than 12 with clinician-diagnosed asthma. Participants are randomized 1:1 to one of two sequences (AB or BA) and receive two puffs of either Symbicort Aerosphere (test) or Symbicort pMDI (reference) in the first period and the alternate device after a 28–42 day washout. Blood samples will be collected after each dose to measure pharmacokinetics of budesonide and formoterol, and safety monitoring will be performed. The trial is multicenter at U.S. research sites and focuses on short-term PK and tolerability rather than long-term clinical outcomes.
Who should consider this trial
Good fit: Children aged 4 to under 12 with clinician-diagnosed asthma for at least 3 months, weighing at least 15 kg, with BMI ≤95th percentile, and on a stable approved asthma regimen are ideal candidates.
Not a fit: Children with other severe respiratory diseases, current lung infections, or a history of life‑threatening asthma are excluded and are unlikely to benefit from participating in this PK-focused study.
Why it matters
Potential benefit: If successful, the results could clarify whether the two devices deliver similar amounts of medicine in children and help guide safer dosing or device choice for pediatric asthma.
How similar studies have performed: Similar pharmacokinetic comparisons of budesonide/formoterol devices have been performed in adults and often show comparable systemic exposure, but pediatric-specific data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participants who have clinician-diagnosed asthma for at least 3 months. * Body mass index ≤ 95 percentile for age and body weight of at least 15 kg or higher. * Be on a stable dose of one of the following asthma treatments for at least 4 weeks prior to screening (Visit 1): 1. Short-acting β2 agonist (SABA) used as rescue/reliever medication (as needed) only. 2. Low- or medium-dose inhaled corticosteroids (ICS). 3. Leukotriene receptor antagonist (LTRA). 4. Low-dose ICS/long-acting β2-agonist (LABA). 5. Medium-dose ICS/LABA. * Female participants who experience menarche must have a negative urine pregnancy test at screening. Key Exclusion Criteria: * 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. * Inability to change from any budesonide therapy to another suitable corticosteroid. * Participants with a known hypersensitivity to budesonide and/or formoterol fumarate or any of the excipients of the product. * Not be able to refrain from consuming alcohol and smoking (including electronic cigarettes, vaping, and marijuana) from the time of screening until after the safety follow-up visit. * Unstable asthma. * Received regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication. * Evidence of active liver disease. * Prolonged QT interval corrected for heart rate using Fridericia's correction (QTcF).
Where this trial is running
Long Beach, California and 5 other locations
- Research Site — Long Beach, California, United States (Recruiting)
- Research Site — Miami, Florida, United States (Recruiting)
- Research Site — Lafayette, Louisiana, United States (Recruiting)
- Research Site — Toledo, Ohio, United States (Recruiting)
- Research Site — Boerne, Texas, United States (Recruiting)
- Research Site — El Paso, Texas, United States (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.