Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00163501
Collaborator
(none)
600
41
16
14.6
0.9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Dec 1, 2003
Actual Primary Completion Date
:
Apr 1, 2005
Actual Study Completion Date
:
Apr 1, 2005
Outcome Measures
Primary Outcome Measures
- change in Total Nasal Symptom Scores. []
Secondary Outcome Measures
- change in symptoms, quality of life, safety. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Altana Pharma/Nycomed | Encinitas | California | United States | 92024 |
| 2 | Altana Pharma/Nycomed | Huntington Beach | California | United States | 92647 |
| 3 | Altana Pharma/Nycomed | Long Beach | California | United States | 90806 |
| 4 | Altana Pharma/Nycomed | Los Angeles | California | United States | 90025 |
| 5 | Altana Pharma/Nycomed | Mission Viejo | California | United States | 92691 |
| 6 | Altana Pharma/Nycomed | Newport Beach | California | United States | 92660 |
| 7 | Altana Pharma/Nycomed | San Diego | California | United States | 92103 |
| 8 | Altana Pharma/Nycomed | San Diego | California | United States | 92120 |
| 9 | Altana Pharma/Nycomed | Stockton | California | United States | 95207 |
| 10 | Altana Pharma/Nycomed | Vista | California | United States | 92083 |
| 11 | Altana Pharma/Nycomed | Trumbull | Connecticut | United States | 06611 |
| 12 | Altana Pharma/Nycomed | Clearwater | Florida | United States | 33761 |
| 13 | Altana Pharma/Nycomed | Deland | Florida | United States | 32720 |
| 14 | Altana Pharma/Nycomed | Atlanta | Georgia | United States | 30342 |
| 15 | Altana Pharma/Nycomed | Normal | Illinois | United States | 61761 |
| 16 | Altana Pharma/Nycomed | Overland Park | Kansas | United States | 66210 |
| 17 | Altana Pharma/Nycomed | New Orleans | Louisiana | United States | 70112 |
| 18 | Altana Pharma/Nycomed | Bethesda | Maryland | United States | 20814 |
| 19 | Altana Pharma/Nycomed | North Dartmouth | Massachusetts | United States | 02747 |
| 20 | Altana Pharma/Nycomed | Forked River | New Jersey | United States | 08731 |
| 21 | Altana Pharma/Nycomed | Skillman | New Jersey | United States | 08558 |
| 22 | Altana Pharma/Nycomed | Springfield | New Jersey | United States | 07081 |
| 23 | Altana Pharma/Nycomed | Liverpool | New York | United States | 13088 |
| 24 | Altana Pharma/Nycomed | Raleigh | North Carolina | United States | 27607 |
| 25 | Altana Pharma/Nycomed | Winston-Salem | North Carolina | United States | 27103 |
| 26 | Altana Pharma/Nycomed | Cincinnati | Ohio | United States | 45219 |
| 27 | Altana Pharma/Nycomed | Cincinnati | Ohio | United States | 45246 |
| 28 | Altana Pharma/Nycomed | Oklahoma | Oklahoma | United States | 73104 |
| 29 | Altana Pharma/Nycomed | Portland | Oregon | United States | 97213 |
| 30 | Altana Pharma/Nycomed | Easton | Pennsylvania | United States | 18045 |
| 31 | Altana Pharma/Nycomed | Pittsburgh | Pennsylvania | United States | 15241 |
| 32 | Altana Pharma/Nycomed | Cranston | Rhode Island | United States | 02920 |
| 33 | Altana Pharma/Nycomed | Austin | Texas | United States | 78731 |
| 34 | Altana Pharma/Nycomed | Dallas | Texas | United States | 75231 |
| 35 | Altana Pharma/Nycomed | Houston | Texas | United States | 77054 |
| 36 | Altana Pharma/Nycomed | Kerrville | Texas | United States | 78028 |
| 37 | Altana Pharma/Nycomed | New Braunfels | Texas | United States | 78130 |
| 38 | Altana Pharma/Nycomed | San Antonio | Texas | United States | 78229 |
| 39 | Altana Pharma/Nycomed | Salt Lake City | Utah | United States | 84111 |
| 40 | Altana Pharma/Nycomed | Richmond | Virginia | United States | 23226 |
| 41 | Altana Pharma/Nycomed | Milwaukee | Wisconsin | United States | 53201 |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: AstraZeneca AstraZeneca, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00163501
Other Study ID Numbers:
- BY9010/M1-404
First Posted:
Sep 14, 2005
Last Update Posted:
Nov 30, 2016
Last Verified:
Oct 1, 2016
Keywords provided by AstraZeneca
Additional relevant MeSH terms: