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
AstraZeneca
Summary
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 - 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…
Eligibility
- Age range
- 4–12 years
- Sex
- All
- Healthy volunteers
- No
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 experi…
Interventions
- Combination ProductBudesonide/formoterol fumarate Aerosphere
Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations.
- Combination ProductBudesonide/formoterol fumarate pMDI
Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations.
Locations (6)
- Research SiteLong Beach, California
- Research SiteMiami, Florida
- Research SiteLafayette, Louisiana
- Research SiteToledo, Ohio
- Research SiteBoerne, Texas
- Research SiteEl Paso, Texas