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A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)

NCT01654536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 737

Last updated 2014-07-24

Study results available
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Summary

This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

ciclesonide nasal aerosol

ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)

DRUG

ciclesonide nasal spray

ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Respiratory Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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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 NCT01654536 on ClinicalTrials.gov