Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
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
1 other identifier
interventional
636
2 countries
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Shorter than P25 for phase_3
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedDecember 2, 2016
October 1, 2016
1.2 years
September 12, 2005
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in Total Nasal Symptom Score
Secondary Outcomes (1)
safety, changes in symptoms
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (74)
Altana Pharma/Nycomed
Oxford, Alabama, 36203, United States
Altana Pharma/Nycomed
Huntington Beach, California, 92647, United States
Altana Pharma/Nycomed
Mission Viejo, California, 92691, United States
Altana Pharma/Nycomed
Newport Beach, California, CA 92660, United States
Altana Pharma/Nycomed
Orange, California, 92868, United States
Altana Pharma/Nycomed
Palmdale, California, 93551, United States
Altana Pharma/Nycomed
San Diego, California, 92120, United States
Altana Pharma/Nycomed
San Diego, California, 92123, United States
Altana Pharma/Nycomed
San Jose, California, 95117, United States
Altana Pharma/Nycomed
Stockton, California, 95207, United States
Altana Pharma/Nycomed
Walnut Creek, CA, California, 94598, United States
Altana Pharma/Nycomed
Coral Gables, Florida, 33134, United States
Altana Pharma/Nycomed
Ocala, Florida, 34471, United States
Altana Pharma/Nycomed
Atlanta, Georgia, 30342, United States
Altana Pharma/Nycomed
Gainesville, Georgia, 30501, United States
Altana Pharma/Nycomed
Savannah, Georgia, 31406, United States
Altana Pharma/Nycomed
Normal, Illinois, 61761, United States
Altana Pharma/Nycomed
Indianapolis, Indiana, 46208, United States
Altana Pharma/Nycomed
Dubuque, Iowa, 52001, United States
Altana Pharma/Nycomed
Overland Park, Kansas, 66210, United States
Altana Pharma/Nycomed
Metairie, Louisiana, 70001, United States
Altana Pharma/Nycomed
Shreveport, Louisiana, 71130, United States
Altana Pharma/Nycomed
Rockville, Maryland, 20850, United States
Altana Pharma/Nycomed
Wheaton, Maryland, 20902, United States
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, 02747, United States
Altana Pharma/Nycomed
Minneapolis, Minnesota, 55402, United States
Altana Pharma/Nycomed
Jefferson City, Missouri, 65101, United States
Altana Pharma/Nycomed
Rolla, Mo, Missouri, 65401, United States
Altana Pharma/Nycomed
St Louis, Missouri, 63141, United States
Altana Pharma/Nycomed
Papillion, Nebraska, 68046, United States
Altana Pharma/Nycomed
Brick, New Jersey, 08724, United States
Altana Pharma/Nycomed
Skillman, New Jersey, 08558, United States
Altana Pharma/Nycomed
Liverpool, New York, 13088, United States
Altana Pharma/Nycomed
Raleigh, North Carolina, 27607, United States
Altana Pharma/Nycomed
Canton, Ohio, 44718, United States
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, 45231, United States
Altana Pharma/Nycomed
Sylvania, Ohio, 43560, United States
Altana Pharma/Nycomed
Medford, Oregon, 97504, United States
Altana Pharma/Nycomed
Portland, Oregon, 97213, United States
Altana Pharma/Nycomed
Easton, Pennsylvania, 18045, United States
Altana Pharma/Nycomed
Hershey, Pennsylvania, 17033, United States
Altana Pharma/Nycomed
Upland, Pennsylvania, 19013, United States
Altana Pharma/Nycomed
Charleston, South Carolina, 29407, United States
Altana Pharma/Nycomed
Charleston, South Carolina, 29414, United States
Altana Pharma/Nycomed
Moncks Corner, South Carolina, 29461, United States
Altana Pharma/Nycomed
Spartanburg, South Carolina, 29307, United States
Altana Pharma/Nycomed
Austin, Texas, 78750, United States
Altana Pharma/Nycomed
El Paso, Texas, 79925, United States
Altana Pharma/Nycomed
Fort Worth, Texas, 76132, United States
Altana Pharma/Nycomed
Friendswood, Texas, 77546, United States
Altana Pharma/Nycomed
Houston, Texas, 77054, United States
Altana Pharma/Nycomed
Katy, Texas, 77450, United States
Altana Pharma/Nycomed
Salt Lake City, Utah, 84037, United States
Altana Pharma/Nycomed
South Burlington, Vermont, 05403, United States
Altana Pharma/Nycomed
Burke, Virginia, 22015, United States
Altana Pharma/Nycomed
Richmond, Virginia, 23219, United States
Altana Pharma/Nycomed
Richmond, Virginia, 23226, United States
Altana Pharma/Nycomed
Spokane, Washington, 99202, United States
Altana Pharma/Nycomed
Hamilton, L8N 3Z5, Canada
Altana Pharma/Nycomed
Hamilton, on, L8N 1Y2, Canada
Altana Pharma/Nycomed
Kanata, on, K2L 3C8, Canada
Altana Pharma/Nycomed
London, N6C 4Y7, Canada
Altana Pharma/Nycomed
London,ON, N6A1V2, Canada
Altana Pharma/Nycomed
Mississauga, L5B 1N1, Canada
Altana Pharma/Nycomed
Montreal, QC, H3T 1C5, Canada
Altana Pharma/Nycomed
Niagara Falls, L2G 1J4, Canada
Altana Pharma/Nycomed
Oshawa, on, L1H1B9, Canada
Altana Pharma/Nycomed
Ottawa, K1Y 4G2, Canada
Altana Pharma/Nycomed
Ottawa, on, K1S 0G8, Canada
Altana Pharma/Nycomed
Saskatoon,SK, S7H 0W2, Canada
Altana Pharma/Nycomed
Ste-Foy PQ, G1V 4M6, Canada
Altana Pharma/Nycomed
Toronto, M4V 1R2, Canada
Altana Pharma/Nycomed
Toronto, on, M3H 5S4, Canada
Altana Pharma/Nycomed
Winnipeg, R2M 5L9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
May 1, 2004
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
December 2, 2016
Record last verified: 2016-10