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
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
16actual
Sites
6
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-05 | actual | When the study began enrolling |
| Primary completion | 2026-06-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-26 | actual | The whole study's end, after follow-up |
| First posted | 2026-02-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Asthma
Interventions
- Combination product: Budesonide/formoterol fumarate Aerosphere
- Combination product: Budesonide/formoterol fumarate pMDI
Primary outcomes
what the primary-completion date above is the date OFMaximum observed plasma concentration (Cmax)
measured Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 8 hours postdose
Area under the plasma concentration-time curve from time 0 to 6 hours postdose (AUC0-6)
measured Participants < 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 3 hours, and 6 hours postdose; Participants ≥ 30 kg: Predose, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours and 6 hours postdose
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