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A Phase 1, Open Label, Two Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution Following Nasal Inhalation of a Novel Nasal Metered Dose Inhaler (MDI) and of a Mometasone Furoate Monohydrate Radiolabeled Suspension Via an Aqueous (AQ) Nasal Spray
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.
Details
| Lead sponsor | Sumitomo Pharma America, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 14 |
| Start date | 2011-06 |
| Completion | 2011-08 |
Conditions
- Allergic Rhinitis (AR)
Interventions
- ciclesonide nasal aerosol
- mometasone Aqueous (AQ) nasal spray
Primary outcomes
- Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose — Day 1 at 2 minutes post dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
Countries
United Kingdom