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

This study has been completed.
Information provided by:
Takeda Identifier:
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
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: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • changes in Total Nasal Symptom Score

Secondary Outcome Measures:
  • safety, changes in symptoms

Estimated Enrollment: 636
Study Start Date: May 2004
Estimated Study Completion Date: February 2005

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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
  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 identifier: NCT00163514

  Show 74 Study Locations
Sponsors and Collaborators
Study Chair: Mark A. Wingertzahn, Ph.D. Altana Pharma, Florham Park, NJ 07932, USA
  More Information Identifier: NCT00163514     History of Changes
Other Study ID Numbers: BY9010/M1-403 
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2016