Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Long Beach, 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
History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Main Exclusion Criteria:

Participation in any investigational drug trial within the 30 days before the screening visit
Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
A known hypersensitivity to any corticosteroid

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

Safety and tolerability of ciclesonide nasal spray

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Dec 5, 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