Clinical trial NCT00305487: Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hay Fever
Seasonal Allergic Rhinitis
Keywords: Hay Fever
Seasonal Allergic Rhinitis
Nasal spray
Ciclesonide
Allergic Rhinitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 660
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent
* General good health other than seasonal allergic rhinitis
* Positive standard skin prick test

Main Exclusion Criteria:

* 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

Primary outcomes:
measure: Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Secondary outcomes:
measure: Physician assessment of nasal symptoms score at endpoint
measure: average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
measure: safety
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Altana Pharma/Nycomed
state: Alabama
city: Hot Springs
country: United States
facility: Altana Pharma/Nycomed
state: Arkansas
city: Costa Mesa
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Huntington Beach
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Long Beach
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Los Alamitos
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Mission Viejo
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Orange
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Roseville
country: United States
facility: Altana Pharma/Nycomed
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed
state: California
city: San Jose
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Stockton
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Colorado Springs
country: United States
facility: Altana Pharma/Nycomed
state: Colorado
city: Denver
country: United States
facility: Altana Pharma/Nycomed
state: Colorado
city: Englewood
country: United States
facility: Altana Pharma/Nycomed
state: Colorado
city: Lakewood, CO
country: United States
facility: Altana Pharma/Nycomed
state: Colorado
city: Atlanta
country: United States
facility: Altana Pharma/Nycomed
state: Georgia
city: Gainesville
country: United States
facility: Altana Pharma/Nycomed
state: Georgia
city: Savannah
country: United States
facility: Altana Pharma/Nycomed
state: Georgia
city: Woodstock, GA
country: United States
facility: Altana Pharma/Nycomed
state: Georgia
city: Normal
country: United States
facility: Altana Pharma/Nycomed
state: Illinois
city: Indianapolis
country: United States
facility: Altana Pharma/Nycomed
state: Indiana
city: Overland Park
country: United States
facility: Altana Pharma/Nycomed
state: Kansas
city: Louisville, KY
country: United States
facility: Altana Pharma/Nycomed
state: Kentucky
city: Metairie
country: United States
facility: Altana Pharma/Nycomed
state: Louisiana
city: Shreveport
country: United States
facility: Altana Pharma/Nycomed
state: Louisiana
city: Bethesda
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: North Dartmouth
country: United States
facility: Altana Pharma/Nycomed
state: Massachusetts
city: Minneapolis
country: United States
facility: Altana Pharma/Nycomed
state: Minnesota
city: Jefferson City
country: United States
facility: Altana Pharma/Nycomed
state: Missouri
city: Rolla
country: United States
facility: Altana Pharma/Nycomed
state: Missouri
city: St. Louis
country: United States
facility: Altana Pharma/Nycomed
state: Missouri
city: Lincoln, NE
country: United States
facility: Altana Pharma/Nycomed
state: Nebraska
city: Papillion
country: United States
facility: Altana Pharma/Nycomed
state: Nebraska
city: Brick
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Forked River
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Red Bank
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Skillman
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Warren
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Rochester, NY
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Rockville Centre
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Raleigh
country: United States
facility: Altana Pharma/Nycomed
state: North Carolina
city: Cincinnati, OH
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Cincinnati
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Ashland
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Lake Oswego
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Medford, OR
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Portland
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Blue Bell
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Eerie
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Upland
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Charleston, SC
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Charleston
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Germantown
country: United States
facility: Altana Pharma/Nycomed
state: Tennessee
city: Jackson
country: United States
facility: Altana Pharma/Nycomed
state: Tennessee
city: Austin
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Austin
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Dallas
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: El Paso
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Kerrville
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: New Braunfels
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: San Antonio
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Salt Lake City
country: United States
facility: Altana Pharma/Nycomed
state: Utah
city: South Burlington
country: United States
facility: Altana Pharma/Nycomed
state: Vermont
city: Burke
country: United States
facility: Altana Pharma/Nycomed
state: Virginia
city: Charlottesville
country: United States
facility: Altana Pharma/Nycomed
state: Virginia
city: Richmond
country: United States
facility: Altana Pharma/Nycomed
state: Virginia
city: Milwaukee
country: United States
facility: Altana Pharma/Nycomed
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: