Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-04-23
12
Participants Needed
6
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to less than 12 years with clinician-diagnosed asthma for at least 3 months
- Body weight of at least 15 kg and body mass index at or below the 95th percentile for age
- On a stable dose of one of the following asthma treatments for at least 4 weeks prior to screening: short-acting beta-2 agonist used as needed, low- or medium-dose inhaled corticosteroids, leukotriene receptor antagonist, low-dose inhaled corticosteroid/long-acting beta-2 agonist, or medium-dose inhaled corticosteroid/long-acting beta-2 agonist
- Female participants who have started menstruation must have a negative urine pregnancy test at screening
You will not qualify if you...
- 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 involving loss of consciousness, intubation, or intensive care admission
- History of severe asthma exacerbation within 8 weeks before screening
- Inability to switch from any budesonide therapy to another suitable corticosteroid
- Known allergy to budesonide, formoterol fumarate, or product excipients
- Inability to refrain from alcohol and smoking including electronic cigarettes, vaping, and marijuana during the study
- Unstable asthma condition
- Use of prohibited anti-inflammatory or long-acting bronchodilator asthma medications regularly
- Evidence of active liver disease
- Prolonged QT interval corrected for heart rate using Fridericia's correction (QTcF)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Research Site
Long Beach, California, United States, 90815
Actively Recruiting
2
Research Site
Miami, Florida, United States, 33175
Actively Recruiting
3
Research Site
Lafayette, Louisiana, United States, 70508
Actively Recruiting
4
Research Site
Toledo, Ohio, United States, 43617
Actively Recruiting
5
Research Site
Boerne, Texas, United States, 78006
Actively Recruiting
6
Research Site
El Paso, Texas, United States, 79903
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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