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Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

Primary Purpose

Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

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

About this trial

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

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)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 Main Exclusion Criteria: Participation in any investigational drug trial within the 30 days preceding the Screening Visit A known hypersensitivity to any corticosteroid or any of the excipients in the formulation Use of any prohibited concomitant medications as defined by the study protocol

Sites / Locations

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

Outcomes

Primary Outcome Measures

change in Total Nasal Symptom Scores.

Secondary Outcome Measures

change in symptoms, quality of life, safety.

Full Information

First Posted
September 12, 2005
Last Updated
November 29, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00163501
Brief Title
Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 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
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
change in Total Nasal Symptom Scores.
Secondary Outcome Measure Information:
Title
change in symptoms, quality of life, safety.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 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 Main Exclusion Criteria: Participation in any investigational drug trial within the 30 days preceding the Screening Visit A known hypersensitivity to any corticosteroid or any of the excipients in the formulation Use of any prohibited concomitant medications as defined by the study protocol
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
Encinitas
State/Province
California
ZIP/Postal Code
92024
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 Angeles
State/Province
California
ZIP/Postal Code
90025
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
92660
Country
United States
Facility Name
Altana Pharma/Nycomed
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
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
Normal
State/Province
Illinois
ZIP/Postal Code
61761
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
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
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
Forked River
State/Province
New Jersey
ZIP/Postal Code
08731
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
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
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
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Oklahoma
State/Province
Oklahoma
ZIP/Postal Code
73104
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Altana Pharma/Nycomed
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
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
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
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
84111
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
53201
Country
United States

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4532&filename=BY9010-M1-404-RDS-2005-12-11.pdf
Description
BY9010-M1-404-RDS-2005-12-11.pdf

Learn more about this trial

Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

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