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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00163501

Enrollment

600

Registered

2005-09-14

Start date

2003-12-31

Completion date

2005-04-30

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

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

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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 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

Design outcomes

Primary

Measure	Time frame
change in Total Nasal Symptom Scores.	—

Secondary

Measure	Time frame
change in symptoms, quality of life, safety.	—

Countries

United States

Outcome results

None listed

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