NCT00659841

To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray (200µg Once Daily) in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 12 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.

Conditions

• Rhinitis, Allergic, Seasonal
• Hay Fever

Interventions

Type	Name	Description
DRUG	Ciclesonide	200µg Ciclesonide versus placebo
DRUG	Placebo	placebo

Timeline

• Start date: 2003-12-01
• Primary completion: 2004-12-01
• Completion: 2005-02-01
• First posted: 2008-04-16
• Last updated: 2016-12-02

Locations

6 sites across 1 country: United States