CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
ciclesonide nasal aerosol +1 moredrug
Likely dose
ciclesonide nasal aerosol 37 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01371786
NCT01371786Phase 1Completed
CompareCT.gov

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

Sumitomo Pharma America, Inc.·interventional·Posted Jun 13, 2011·Updated Sep 10, 2012

In Brief

A Phase 1 clinical trial evaluating ciclesonide nasal aerosol and mometasone Aqueous (AQ) nasal spray for Allergic Rhinitis (AR). Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis (AR)
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.1 years ago

Interventions

ciclesonide nasal aerosoldrug

A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister

mometasone Aqueous (AQ) nasal spraydrug

A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle