Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00163514
Collaborator
(none)
636
74
14
8.6
0.6
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:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
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 Start Date
:
May 1, 2004
Actual Primary Completion Date
:
Jul 1, 2005
Actual Study Completion Date
:
Jul 1, 2005
Outcome Measures
Primary Outcome Measures
- changes in Total Nasal Symptom Score []
Secondary Outcome Measures
- safety, changes in symptoms []
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Years
to 11 Years
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Altana Pharma/Nycomed | Oxford | Alabama | United States | 36203 |
| 2 | Altana Pharma/Nycomed | Huntington Beach | California | United States | 92647 |
| 3 | Altana Pharma/Nycomed | Mission Viejo | California | United States | 92691 |
| 4 | Altana Pharma/Nycomed | Newport Beach | California | United States | CA 92660 |
| 5 | Altana Pharma/Nycomed | Orange | California | United States | 92868 |
| 6 | Altana Pharma/Nycomed | Palmdale | California | United States | 93551 |
| 7 | Altana Pharma/Nycomed | San Diego | California | United States | 92120 |
| 8 | Altana Pharma/Nycomed | San Diego | California | United States | 92123 |
| 9 | Altana Pharma/Nycomed | San Jose | California | United States | 95117 |
| 10 | Altana Pharma/Nycomed | Stockton | California | United States | 95207 |
| 11 | Altana Pharma/Nycomed | Walnut Creek, CA | California | United States | 94598 |
| 12 | Altana Pharma/Nycomed | Coral Gables | Florida | United States | 33134 |
| 13 | Altana Pharma/Nycomed | Ocala | Florida | United States | 34471 |
| 14 | Altana Pharma/Nycomed | Atlanta | Georgia | United States | 30342 |
| 15 | Altana Pharma/Nycomed | Gainesville | Georgia | United States | 30501 |
| 16 | Altana Pharma/Nycomed | Savannah | Georgia | United States | 31406 |
| 17 | Altana Pharma/Nycomed | Normal | Illinois | United States | 61761 |
| 18 | Altana Pharma/Nycomed | Indianapolis | Indiana | United States | 46208 |
| 19 | Altana Pharma/Nycomed | Dubuque | Iowa | United States | 52001 |
| 20 | Altana Pharma/Nycomed | Overland Park | Kansas | United States | 66210 |
| 21 | Altana Pharma/Nycomed | Metairie | Louisiana | United States | 70001 |
| 22 | Altana Pharma/Nycomed | Shreveport | Louisiana | United States | 71130 |
| 23 | Altana Pharma/Nycomed | Rockville | Maryland | United States | 20850 |
| 24 | Altana Pharma/Nycomed | Wheaton | Maryland | United States | 20902 |
| 25 | Altana Pharma/Nycomed | North Dartmouth | Massachusetts | United States | 02747 |
| 26 | Altana Pharma/Nycomed | Minneapolis | Minnesota | United States | 55402 |
| 27 | Altana Pharma/Nycomed | Jefferson City | Missouri | United States | 65101 |
| 28 | Altana Pharma/Nycomed | Rolla, Mo | Missouri | United States | 65401 |
| 29 | Altana Pharma/Nycomed | St. Louis | Missouri | United States | 63141 |
| 30 | Altana Pharma/Nycomed | Papillion | Nebraska | United States | 68046 |
| 31 | Altana Pharma/Nycomed | Brick | New Jersey | United States | 08724 |
| 32 | Altana Pharma/Nycomed | Skillman | New Jersey | United States | 08558 |
| 33 | Altana Pharma/Nycomed | Liverpool | New York | United States | 13088 |
| 34 | Altana Pharma/Nycomed | Raleigh | North Carolina | United States | 27607 |
| 35 | Altana Pharma/Nycomed | Canton | Ohio | United States | 44718 |
| 36 | Altana Pharma/Nycomed | Cincinnati, OH | Ohio | United States | 45231 |
| 37 | Altana Pharma/Nycomed | Sylvania | Ohio | United States | 43560 |
| 38 | Altana Pharma/Nycomed | Medford | Oregon | United States | 97504 |
| 39 | Altana Pharma/Nycomed | Portland | Oregon | United States | 97213 |
| 40 | Altana Pharma/Nycomed | Easton | Pennsylvania | United States | 18045 |
| 41 | Altana Pharma/Nycomed | Hershey | Pennsylvania | United States | 17033 |
| 42 | Altana Pharma/Nycomed | Upland | Pennsylvania | United States | 19013 |
| 43 | Altana Pharma/Nycomed | Charleston | South Carolina | United States | 29407 |
| 44 | Altana Pharma/Nycomed | Charleston | South Carolina | United States | 29414 |
| 45 | Altana Pharma/Nycomed | Moncks Corner | South Carolina | United States | 29461 |
| 46 | Altana Pharma/Nycomed | Spartanburg | South Carolina | United States | 29307 |
| 47 | Altana Pharma/Nycomed | Austin | Texas | United States | 78750 |
| 48 | Altana Pharma/Nycomed | El Paso | Texas | United States | 79925 |
| 49 | Altana Pharma/Nycomed | Fort Worth | Texas | United States | 76132 |
| 50 | Altana Pharma/Nycomed | Friendswood | Texas | United States | 77546 |
| 51 | Altana Pharma/Nycomed | Houston | Texas | United States | 77054 |
| 52 | Altana Pharma/Nycomed | Katy | Texas | United States | 77450 |
| 53 | Altana Pharma/Nycomed | Salt Lake City | Utah | United States | 84037 |
| 54 | Altana Pharma/Nycomed | South Burlington | Vermont | United States | 05403 |
| 55 | Altana Pharma/Nycomed | Burke | Virginia | United States | 22015 |
| 56 | Altana Pharma/Nycomed | Richmond | Virginia | United States | 23219 |
| 57 | Altana Pharma/Nycomed | Richmond | Virginia | United States | 23226 |
| 58 | Altana Pharma/Nycomed | Spokane | Washington | United States | 99202 |
| 59 | Altana Pharma/Nycomed | Hamilton, ON | Canada | L8N 1Y2 | |
| 60 | Altana Pharma/Nycomed | Hamilton | Canada | L8N 3Z5 | |
| 61 | Altana Pharma/Nycomed | Kanata, ON | Canada | K2L 3C8 | |
| 62 | Altana Pharma/Nycomed | London,ON | Canada | N6A1V2 | |
| 63 | Altana Pharma/Nycomed | London | Canada | N6C 4Y7 | |
| 64 | Altana Pharma/Nycomed | Mississauga | Canada | L5B 1N1 | |
| 65 | Altana Pharma/Nycomed | Montreal, QC | Canada | H3T 1C5 | |
| 66 | Altana Pharma/Nycomed | Niagara Falls | Canada | L2G 1J4 | |
| 67 | Altana Pharma/Nycomed | Oshawa, ON | Canada | L1H1B9 | |
| 68 | Altana Pharma/Nycomed | Ottawa, ON | Canada | K1S 0G8 | |
| 69 | Altana Pharma/Nycomed | Ottawa | Canada | K1Y 4G2 | |
| 70 | Altana Pharma/Nycomed | Saskatoon,SK | Canada | S7H 0W2 | |
| 71 | Altana Pharma/Nycomed | Ste-Foy PQ | Canada | G1V 4M6 | |
| 72 | Altana Pharma/Nycomed | Toronto, ON | Canada | M3H 5S4 | |
| 73 | Altana Pharma/Nycomed | Toronto | Canada | M4V 1R2 | |
| 74 | Altana Pharma/Nycomed | Winnipeg | Canada | R2M 5L9 |
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:
NCT00163514
Other Study ID Numbers:
- BY9010/M1-403
First Posted:
Sep 14, 2005
Last Update Posted:
Dec 2, 2016
Last Verified:
Oct 1, 2016
Keywords provided by AstraZeneca
Additional relevant MeSH terms: