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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00163501
First received: September 12, 2005
Last updated: November 29, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • change in Total Nasal Symptom Scores.

Secondary Outcome Measures:
  • change in symptoms, quality of life, safety.

Estimated Enrollment: 600
Study Start Date: December 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163501

  Show 41 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163501     History of Changes
Other Study ID Numbers: BY9010/M1-404 
Study First Received: September 12, 2005
Last Updated: November 29, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Allergy
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on December 08, 2016