Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

AstraZeneca600 enrolled

Overview

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever

Interventions

CiclesonideDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Main Inclusion Criteria: * General good health, other than perennial allergic rhinitis * History and diagnosis of perennial allergic rhinitis by skin prick test Main Exclusion Criteria: * Participation in any investigational drug trial within the 30 days preceding the Screening Visit * A known hypersensitivity to any corticosteroid or any of the excipients in the formulation * Use of any prohibited concomitant medications as defined by the study protocol

Locations (41)

Outcomes

Primary Outcomes

change in Total Nasal Symptom Scores.

Secondary Outcomes

change in symptoms, quality of life, safety.

Data from ClinicalTrials.gov

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Altana Pharma/Nycomed

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Long Beach, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Vista, California, United States

...and 31 more locations