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

Phase 3
Completed
Conditions
Hay Fever
Perennial Allergic Rhinitis
Allergic Rhinitis
Registration Number
NCT00163501
Lead Sponsor
AstraZeneca
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
600
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
change in Total Nasal Symptom Scores.
Secondary Outcome Measures
NameTimeMethod
change in symptoms, quality of life, safety.

Trial Locations

Locations (1)

Altana Pharma/Nycomed

🇺🇸

Milwaukee, Wisconsin, United States

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