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

Phase 3

Completed

• Conditions: Hay Fever; Perennial Allergic Rhinitis

• Registration Number: NCT00261287
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ciclesonide nasal spray

Trial Locations

Locations (1)

Altana Pharma/Nycomed; 🇺🇸 San Antonio, Texas, United States