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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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, Onc

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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Onset of action, measured by change from baseline in Total Nasal Symptom Score.

Original Primary Outcome: Same as current

Current Secondary Outcome: changes in symptoms, safety.

Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: October 5, 2006
Date Started: October 2006
Date Completion:
Last Updated: November 29, 2016
Last Verified: October 2016