NCT00384475

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Seasonal
• Hay Fever

Interventions

Type	Name	Description
DRUG	Ciclesonide Nasal Spray

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2006-10-06
• Last updated: 2016-11-30

Locations

1 site across 1 country: Canada