Not Signed In -
Hay Fever |
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Clinical Trial: Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 y)
This study is not yet open for patient recruitment.
Verified by ALTANA Pharma December 2005
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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 Allergic Rhinitis Perennial Allergic Rhinitis | Drug: Ciclesonide | Phase III |
MedlinePlus related topics: Allergy; Lung Diseases; Nose Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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
Further study details as provided by ALTANA Pharma:
Primary Outcomes: Safety and tolerability of ciclesonide nasal spray.
Expected Total Enrollment: 102
Expected Total Enrollment: 102
Study start: November 2005
Eligibility
Ages Eligible for Study: 2 Years - 5 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00261287
Mark A. Wingertzahn, PhD info.clintrials@altanapharma.com
California
ALTANA Investigational Site 5212, Long Beach, California, 90806, United States
Illinois
ALTANA Investigational Site 4789, Normal, Illinois, 61761, United States
Texas
ALTANA Investigational Site 4820, San Antonio, Texas, 78229, United States
Study chairs or principal investigators
Mark A. Wingertzahn, Ph.D., Study Chair, Altana Pharma, Florham Park, NJ 07932, USA, info.clintrials@altanapharma.com
More Information
Study ID Numbers: BY9010/M1-416
Last Updated: December 8, 2005
Record first received: December 2, 2005
ClinicalTrials.gov Identifier: NCT00261287
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: December 2, 2005
ClinicalTrials.gov Identifier: NCT00261287
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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