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

Primary Purpose

Hay Fever, Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ciclesonide nasal spray
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hay Fever focused on measuring Hay Fever, Seasonal Allergic Rhinitis, Nasal spray, Ciclesonide, Allergic Rhinitis

Eligibility Criteria

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

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

Sites / Locations

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

Outcomes

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

Full Information

First Posted
March 21, 2006
Last Updated
November 29, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00305487
Brief Title
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hay Fever, Seasonal Allergic Rhinitis
Keywords
Hay Fever, Seasonal Allergic Rhinitis, Nasal spray, Ciclesonide, Allergic Rhinitis

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide nasal spray
Primary Outcome Measure Information:
Title
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Secondary Outcome Measure Information:
Title
Physician assessment of nasal symptoms score at endpoint
Title
average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
Title
safety

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: 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
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
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
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
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
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Roseville
State/Province
California
ZIP/Postal Code
95678
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
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Lakewood, CO
State/Province
Colorado
ZIP/Postal Code
80401
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
Woodstock, GA
State/Province
Georgia
ZIP/Postal Code
30188
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
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Louisville, KY
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
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
65109
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Rolla
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
Lincoln, NE
State/Province
Nebraska
ZIP/Postal Code
68505
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
Forked River
State/Province
New Jersey
ZIP/Postal Code
08731
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
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
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Rochester, NY
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
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
Cincinnati, OH
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Medford, OR
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
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Eerie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
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, SC
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
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
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
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Altana Pharma/Nycomed
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Altana Pharma/Nycomed
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
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
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4540&filename=BY9010-M1-417-RDS-2007-04-27.pdf
Description
BY9010-M1-417-RDS-2007-04-27.pdf

Learn more about this trial

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

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