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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00261287

Enrollment

102

Registered

2005-12-05

Start date

2005-11-30

Completion date

2006-06-30

Last updated

2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hay Fever, Perennial Allergic Rhinitis

Keywords

Hay Fever, Allergic Rhinitis, Perennial Allergic Rhinitis, Ciclesonide

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.

Interventions

DRUGCiclesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of ciclesonide nasal spray	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026