Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00163514

Enrollment

636

Registered

2005-09-14

Start date

2004-05-31

Completion date

2005-07-31

Last updated

2016-12-02

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

Conditions

Allergic Rhinitis, Hay Fever, Perennial Allergic Rhinitis

Keywords

Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Brief summary

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.

Interventions

DRUGCiclesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 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 * Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.) Main

Exclusion criteria

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial * Use of any prohibited concomitant medications as defined by the study protocol * Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Design outcomes

Primary

Measure	Time frame
changes in Total Nasal Symptom Score	—

Secondary

Measure	Time frame
safety, changes in symptoms	—

Countries

Canada, United States

Outcome results

None listed

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