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A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

NCT01458275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 847

Last updated 2014-05-15

Study results available
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Summary

This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Ciclesonide nasal aerosol 37 mcg

ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg

DRUG

ciclesonide nasal aerosol 74 mcg

ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg

DRUG

Placebo

Placebo - one actuation per nostril

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01458275 on ClinicalTrials.gov