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placebo + dexamethasone
- Development stage
- Unknown
- Lead developer
- Sumitomo Pharma America
- Modality
- Small Molecules
- Administration
- Oral, Intranasal
01
Overview
The combination of **placebo + dexamethasone** refers to a specific positive control intervention used in clinical trials conducted by Sumitomo Pharma America (formerly Sepracor) to evaluate the safety and efficacy of ciclesonide formulations, such as Zetonna and Omnaris. This intervention consists of a nasal placebo (either a hydrofluoroalkane [HFA] aerosol or an aqueous spray) administered alongside oral dexamethasone, typically at a dose of 6 mg daily. Dexamethasone is a potent synthetic glucocorticoid that acts as a high-affinity agonist of the glucocorticoid receptor. In these studies, it serves as a positive control to demonstrate the sensitivity of the assay in detecting suppression of the hypothalamic-pituitary-adrenal (HPA) axis. While the trials were focused on patients with perennial allergic rhinitis, dexamethasone itself is a widely used anti-inflammatory and immunosuppressive agent across various medical conditions.
- Other names
- Placebo plus Dexamethasone HFAPlacebo AQ plus Dexamethasone 6 mgPlacebo plus Dexamethasone
02
Targets
GR (Glucocorticoid receptor)
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