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A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

NCT00953147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1110

Last updated 2012-06-13

Study results available
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Summary

This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Conditions

  • Allergic Rhinitis
  • Perennial Allergic Rhinitis

Interventions

DRUG

Ciclesonide HFA 80 mcg

Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

DRUG

Ciclesonide HFA 160 mcg

Ciclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

DRUG

Placebo

Placebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-01-31
Completion
2010-05-31

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 NCT00953147 on ClinicalTrials.gov