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Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00261287
First received: December 2, 2005
Last updated: May 4, 2012
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.


Condition Intervention Phase
Hay Fever
Perennial Allergic Rhinitis
Drug: Ciclesonide
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 Tolerability of Ciclesonide (200 Mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Safety and tolerability of ciclesonide nasal spray

Estimated Enrollment: 102
Study Start Date: November 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
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
  • History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Main Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days before the screening visit
  • Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
  • A known hypersensitivity to any corticosteroid
  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: NCT00261287

Locations
United States, California
Altana Pharma/Nycomed
Long Beach, California, United States, 90806
United States, Illinois
Altana Pharma/Nycomed
Normal, Illinois, United States, 61761
United States, Texas
Altana Pharma/Nycomed
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Mark A. Wingertzahn, PhD ALTANA Pharma, Florham Park, NJ 07932, USA
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00261287     History of Changes
Other Study ID Numbers: BY9010/M1-416
Study First Received: December 2, 2005
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014