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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

NCT00790023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2016-04-08

Study results available
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Summary

To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

80 mcg Ciclesonide

80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)

DRUG

160 mcg Ciclesonide

160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)

DRUG

Placebo

Placebo HFA Inhaler once daily (one actuation per nostril)

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-02-28
Completion
2009-02-28

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 NCT00790023 on ClinicalTrials.gov