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

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.

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Key information

Conditions

Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Encinitas, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

change in Total Nasal Symptom Scores.

Secondary outcomes

change in symptoms, quality of life, safety.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Sep 14, 2005
Registry last updated: Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed