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

Primary Purpose

Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perennial Allergic Rhinitis focused on measuring Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
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Outcomes

Primary Outcome Measures

changes in Total Nasal Symptom Score

Secondary Outcome Measures

safety, changes in symptoms

Full Information

First Posted
September 12, 2005
Last Updated
December 1, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00163514
Brief Title
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (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 investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
Keywords
Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
636 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
changes in Total Nasal Symptom Score
Secondary Outcome Measure Information:
Title
safety, changes in symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 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 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
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
Oxford
State/Province
Alabama
ZIP/Postal Code
36203
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Newport Beach
State/Province
California
ZIP/Postal Code
CA 92660
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Altana Pharma/Nycomed
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Altana Pharma/Nycomed
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Altana Pharma/Nycomed
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Walnut Creek, CA
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
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
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Altana Pharma/Nycomed
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Rolla, Mo
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Altana Pharma/Nycomed
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Cincinnati, OH
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Altana Pharma/Nycomed
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84037
Country
United States
Facility Name
Altana Pharma/Nycomed
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Hamilton, ON
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Kanata, ON
ZIP/Postal Code
K2L 3C8
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
London,ON
ZIP/Postal Code
N6A1V2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
London
ZIP/Postal Code
N6C 4Y7
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Mississauga
ZIP/Postal Code
L5B 1N1
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Montreal, QC
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Niagara Falls
ZIP/Postal Code
L2G 1J4
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Oshawa, ON
ZIP/Postal Code
L1H1B9
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Ottawa, ON
ZIP/Postal Code
K1S 0G8
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Ottawa
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Saskatoon,SK
ZIP/Postal Code
S7H 0W2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Ste-Foy PQ
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Toronto, ON
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Toronto
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Winnipeg
ZIP/Postal Code
R2M 5L9
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4531&filename=BY9010-M1-403-RDS-2005-12-09.pdf
Description
BY9010-M1-403-RDS-2005-12-09.pdf

Learn more about this trial

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

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