drugset / Trial / NCT06589245
Inhaled Ciclesonide Study in Preterm Infants
Phase 1
Recruiting
30 enrolled
Venkatesh Sampath
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabUniversity of Pittsburgh · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).
Timeline
- Start
- 2025-09-16
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciclesonide | Other / unclassified | 80 ug | Inhaled |
| Subject | Ciclesonide | Other / unclassified | 160 ug | Inhaled |