Back to resultsSafety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
Primary Purpose
Hay Fever, Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
About this trial
This is an interventional treatment trial for Hay Fever focused on measuring Hay Fever, Allergic Rhinitis, Perennial Allergic Rhinitis, Ciclesonide
Eligibility 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
Sites / Locations
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
Outcomes
Primary Outcome Measures
Safety and tolerability of ciclesonide nasal spray
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00261287
Brief Title
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hay Fever, Perennial Allergic Rhinitis
Keywords
Hay Fever, Allergic Rhinitis, Perennial Allergic Rhinitis, Ciclesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
102 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
Safety and tolerability of ciclesonide nasal spray
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Altana Pharma/Nycomed
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4539&filename=BY9010-M1-416-RDS-2007-03-22.pdf
Description
BY9010-M1-416-RDS-2007-03-22.pdf
Learn more about this trial
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
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