Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
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
1 other identifier
interventional
660
1 country
71
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2006
Shorter than P25 for phase_3
71 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
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedNovember 30, 2016
October 1, 2016
7 months
March 21, 2006
November 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- General good health other than seasonal allergic rhinitis
- Positive standard skin prick test
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (71)
Altana Pharma/Nycomed
Birmingham, Alabama, 35235, United States
Altana Pharma/Nycomed
Hot Springs, Arkansas, 71913, United States
Altana Pharma/Nycomed
Costa Mesa, California, 92626, United States
Altana Pharma/Nycomed
Huntington Beach, California, 92647, United States
Altana Pharma/Nycomed
Long Beach, California, 90806, United States
Altana Pharma/Nycomed
Los Alamitos, California, 90720, United States
Altana Pharma/Nycomed
Mission Viejo, California, 92691, United States
Altana Pharma/Nycomed
Orange, California, 92868, United States
Altana Pharma/Nycomed
Roseville, California, 95678, 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
Colorado Springs, Colorado, 80907, United States
Altana Pharma/Nycomed
Denver, Colorado, 80230, United States
Altana Pharma/Nycomed
Englewood, Colorado, 80112, United States
Altana Pharma/Nycomed
Lakewood, CO, Colorado, 80401, 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
Woodstock, GA, Georgia, 30188, United States
Altana Pharma/Nycomed
Normal, Illinois, 61761, United States
Altana Pharma/Nycomed
Indianapolis, Indiana, 46208, United States
Altana Pharma/Nycomed
Overland Park, Kansas, 66211, United States
Altana Pharma/Nycomed
Louisville, KY, Kentucky, 40215, United States
Altana Pharma/Nycomed
Metairie, Louisiana, 70006, United States
Altana Pharma/Nycomed
Shreveport, Louisiana, 71105, United States
Altana Pharma/Nycomed
Bethesda, Maryland, 20814, 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, 65109, United States
Altana Pharma/Nycomed
Rolla, Missouri, 65401, United States
Altana Pharma/Nycomed
St Louis, Missouri, 63141, United States
Altana Pharma/Nycomed
Lincoln, NE, Nebraska, 68505, United States
Altana Pharma/Nycomed
Papillion, Nebraska, 68046, United States
Altana Pharma/Nycomed
Brick, New Jersey, 08724, United States
Altana Pharma/Nycomed
Forked River, New Jersey, 08731, United States
Altana Pharma/Nycomed
Red Bank, New Jersey, 07701, United States
Altana Pharma/Nycomed
Skillman, New Jersey, 08558, United States
Altana Pharma/Nycomed
Warren Township, New Jersey, 07059, United States
Altana Pharma/Nycomed
Rochester, NY, New York, 14618, United States
Altana Pharma/Nycomed
Rockville Centre, New York, 11570, United States
Altana Pharma/Nycomed
Raleigh, North Carolina, 27607, United States
Altana Pharma/Nycomed
Cincinnati, Ohio, 45219, United States
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, 45231, United States
Altana Pharma/Nycomed
Ashland, Oregon, 97520, United States
Altana Pharma/Nycomed
Lake Oswego, Oregon, 97035, United States
Altana Pharma/Nycomed
Medford, OR, Oregon, 97504, United States
Altana Pharma/Nycomed
Portland, Oregon, 97213, United States
Altana Pharma/Nycomed
Blue Bell, Pennsylvania, 19422, United States
Altana Pharma/Nycomed
Eerie, Pennsylvania, 16506, United States
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15202, United States
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15241, United States
Altana Pharma/Nycomed
Upland, Pennsylvania, 19013, United States
Altana Pharma/Nycomed
Charleston, South Carolina, 29414, United States
Altana Pharma/Nycomed
Charleston, SC, South Carolina, 29407, United States
Altana Pharma/Nycomed
Germantown, Tennessee, 38138, United States
Altana Pharma/Nycomed
Jackson, Tennessee, 38301, United States
Altana Pharma/Nycomed
Austin, Texas, 78731, United States
Altana Pharma/Nycomed
Austin, Texas, 78750, United States
Altana Pharma/Nycomed
Dallas, Texas, 75231, United States
Altana Pharma/Nycomed
El Paso, Texas, 79925, United States
Altana Pharma/Nycomed
Kerrville, Texas, 78028, United States
Altana Pharma/Nycomed
New Braunfels, Texas, 78130, United States
Altana Pharma/Nycomed
San Antonio, Texas, 78229, 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
Charlottesville, Virginia, 22911, United States
Altana Pharma/Nycomed
Richmond, Virginia, 23226, United States
Altana Pharma/Nycomed
Milwaukee, Wisconsin, 53209, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2006
First Posted
March 22, 2006
Study Start
March 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
November 30, 2016
Record last verified: 2016-10