Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07433569
Brief 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.
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.
Study:
NCT07433569
Study Brief:
Protocol Section:
NCT07433569