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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
NCT07433569 · AstraZeneca
In plain English
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Official title
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
About this study
This is a phase I single-dose, 2-period cross-over, multicenter study in which the participants will be randomized 1:1 to one of two treatment sequences - AB or BA. In the first study period, participants will receive a single dose of either -
1. Treatment A: Symbicort Aerosphere budesonide/formoterol fumarate × 2 puffs (test formulation)
2. Treatment B: Symbicort pMDI budesonide/formoterol fumarate × 2 puffs (reference formulation)
After a washout period of at least 28 days and no longer than 42 days, participants who first received Treatment A will receive a single dose of Treatment B, and participants who first received Treatment B will receive a single dose of Treatment A in the study period 2.
Eligibility 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).
Study design
Enrollment target: 12 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2026-03-05
Estimated completion: 2026-10-22
Last updated: 2026-03-12
Interventions
Combination Product: Budesonide/formoterol fumarate AerosphereCombination Product: Budesonide/formoterol fumarate pMDI
Primary outcomes
- • Maximum observed plasma concentration (Cmax) (Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose)
- • Area under the plasma concentration-time curve from time 0 to 6 hours postdose (AUC0-6) (Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours and 6 hours postdose)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (6)
Research SiteRecruiting
Long Beach, California, United States
Research SiteRecruiting
Miami, Florida, United States
Research SiteRecruiting
Lafayette, Louisiana, United States
Research SiteNot Yet Recruiting
Toledo, Ohio, United States
Research SiteRecruiting
Boerne, Texas, United States
Research SiteNot Yet Recruiting
El Paso, Texas, United States