Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

This study has been completed.
Information provided by:
Takeda Identifier:
First received: March 21, 2006
Last updated: May 4, 2012
Last verified: June 2011
The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

Condition Intervention Phase
Hay Fever
Seasonal Allergic Rhinitis
Drug: Ciclesonide nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

Secondary Outcome Measures:
  • Physician assessment of nasal symptoms score at endpoint
  • average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
  • safety

Estimated Enrollment: 660
Study Start Date: March 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • Written informed consent
  • General good health other than seasonal allergic rhinitis
  • Positive standard skin prick test

Main Exclusion Criteria:

  • Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit
  • A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
  • Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
  • Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
  • Use of any prohibited concomitant medications
  • Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
  • Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
  • Study participation by more than one patient from the same household
  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: NCT00305487

  Show 71 Study Locations
Sponsors and Collaborators
Study Chair: Mark A. Wingertzahn, PhD ALTANA Pharma, Florham Park, NJ 07932, USA,
  More Information

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00305487     History of Changes
Other Study ID Numbers: BY9010/M1-417 
Study First Received: March 21, 2006
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Hay Fever
Seasonal Allergic Rhinitis
Nasal spray
Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
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 30, 2016