drugset / Trial / NCT01371786

A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler

NCT01371786

Phase 1 Completed 14 enrolled Sumitomo Pharma America, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2011-06
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciclesonide Other / unclassified 74 ug Intranasal
Comparator Mometasone Other / unclassified 200 ug Intranasal

Indications