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

NCT01371786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-09-10

Study results available
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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.

Conditions

  • Allergic Rhinitis (AR)

Interventions

DRUG

ciclesonide nasal aerosol

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

DRUG

mometasone Aqueous (AQ) nasal spray

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

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01371786 on ClinicalTrials.gov