Overview
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.
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 -
- Treatment A: Symbicort Aerosphere budesonide/formoterol fumarate × 2 puffs (test formulation)
- 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
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):
- Short-acting β2 agonist (SABA) used as rescue/reliever medication (as needed) only.
- Low- or medium-dose inhaled corticosteroids (ICS).
- Leukotriene receptor antagonist (LTRA).
- Low-dose ICS/long-acting β2-agonist (LABA).
- 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).
