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
Purpose
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.
Condition
- Asthma
Eligibility
- Eligible Ages
- Between 4 Years and 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sequence AB |
In study period 1, participants will receive a single dose of treatment A (test formulation) and in study period 2, participants will receive a single dose of treatment B (reference formulation). |
|
|
Experimental Sequence BA |
In study period 1, participants will receive a single dose of treatment B (reference formulation) and in study period 2, participants will receive a single dose of treatment A (test formulation). |
|
Recruiting Locations
Research Site
Long Beach, California 90815
Long Beach, California 90815
Research Site
Miami, Florida 33175
Miami, Florida 33175
Research Site
Lafayette, Louisiana 70508
Lafayette, Louisiana 70508
Research Site
Boerne, Texas 78006
Boerne, Texas 78006
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
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.