We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00163514
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever Drug: Ciclesonide Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age
Study Start Date : May 2004
Primary Completion Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide
U.S. FDA Resources

Primary Outcome Measures :
  1. changes in Total Nasal Symptom Score

Secondary Outcome Measures :
  1. safety, changes in symptoms

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • General good health, other than perennial allergic rhinitis
  • History and diagnosis of perennial allergic rhinitis by skin prick test
  • Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)

Main Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
  • Use of any prohibited concomitant medications as defined by the study protocol
  • Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163514

  Show 74 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163514     History of Changes
Other Study ID Numbers: BY9010/M1-403
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: October 2016

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

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