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Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older

NCT01010971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2012-06-13

Study results available
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Summary

This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Ciclesonide HFA 160 μg

Ciclesonide HFA Nasal Aerosol 160 μg once daily

DRUG

Ciclesonide HFA 80 μg

Ciclesonide HFA Nasal Aerosol 80 μg once daily

DRUG

Placebo

Placebo HFA Nasal Aerosol once daily

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
2009-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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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 NCT01010971 on ClinicalTrials.gov