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

Overview

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.

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: April 2005

Interventions

  • Drug: Ciclesonide

Clinical Trial Outcome Measures

Primary Measures

  • change in Total Nasal Symptom Scores.

Secondary Measures

  • change in symptoms, quality of life, safety.

Participating in This Clinical Trial

Main 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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AstraZeneca AstraZeneca, Study Director, AstraZeneca

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