A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mcg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384475

Enrollment

500

Registered

2006-10-06

Start date

2006-10-31

Completion date

2007-01-31

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, Rhinitis, Allergic, Seasonal

Keywords

Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR

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 seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the exposure to ragweed pollen in a controlled environment. The study duration consists of a baseline period (up to 5 days) and a treatment period (1 day). The study will provide further data on safety and tolerability of ciclesonide.

Interventions

DRUGCiclesonide Nasal Spray

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Written informed consent * General good health * History of SAR to short ragweed pollen for 2 years immediately preceding the study * Demonstrated sensitivity to short ragweed known to induce SAR through a standard skin prick test Main

Exclusion criteria

* Clinically significant physical finding of nasal anatomical deformities causing greater than 50% obstruction, including but not limited to nasal polyps, septal defects, respiratory tract malformations, nasal trauma or surgery * Known hypersensitivity to any corticosteroid * History of a respiratory infection or disorder including but not limited to bronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratory syndrome) within 14 days preceding the Screening Visit * History of alcohol or drug abuse within 2 years preceding the Screening Visit * Active asthma requiring treatment of inhaled or systemic corticosteroids and/or routine use of beta-agonists or any controller drugs * Use of antibiotic therapy for acute conditions within 14 days preceding the Screening Visit * Exposure to systemic corticosteroids for any indication, chronic or intermittent within 60 days preceding the Screening Visit

Design outcomes

Primary

Measure	Time frame
Onset of action, measured by change from baseline in Total Nasal Symptom Score.	—

Secondary

Measure	Time frame
changes in symptoms, safety.	—

Countries

Canada

Outcome results

None listed

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