Study identifier:D7820C00005
ClinicalTrials.gov identifier:NCT07433569
EudraCT identifier:N/A
CTIS identifier:N/A
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
asthma
Phase 1
No
-
All
12
Interventional
4 Years - 12 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2026 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions |
|---|---|
| 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). | Combination Product: Budesonide/formoterol fumarate Aerosphere Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations. Combination Product: Budesonide/formoterol fumarate pMDI Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations. |
| 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). | Combination Product: Budesonide/formoterol fumarate Aerosphere Participants will receive budesonide/formoterol fumarate aerosphere as oral inhalations. Combination Product: Budesonide/formoterol fumarate pMDI Participants will receive budesonide/formoterol fumarate pMDI as oral inhalations. |