Clinical trial NCT00163514: Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Keywords: Allergy
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 636
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes in Total Nasal Symptom Score
Secondary outcomes:
measure: safety, changes in symptoms
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Altana Pharma/Nycomed
state: Alabama
city: Huntington Beach
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Mission Viejo
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Newport Beach
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Orange
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Palmdale
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: Walnut Creek, CA
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Coral Gables
country: United States
facility: Altana Pharma/Nycomed
state: Florida
city: Ocala
country: United States
facility: Altana Pharma/Nycomed
state: Florida
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: Normal
country: United States
facility: Altana Pharma/Nycomed
state: Illinois
city: Indianapolis
country: United States
facility: Altana Pharma/Nycomed
state: Indiana
city: Dubuque
country: United States
facility: Altana Pharma/Nycomed
state: Iowa
city: Overland Park
country: United States
facility: Altana Pharma/Nycomed
state: Kansas
city: Metairie
country: United States
facility: Altana Pharma/Nycomed
state: Louisiana
city: Shreveport
country: United States
facility: Altana Pharma/Nycomed
state: Louisiana
city: Rockville
country: United States
facility: Altana Pharma/Nycomed
state: Maryland
city: Wheaton
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, Mo
country: United States
facility: Altana Pharma/Nycomed
state: Missouri
city: St. Louis
country: United States
facility: Altana Pharma/Nycomed
state: Missouri
city: Papillion
country: United States
facility: Altana Pharma/Nycomed
state: Nebraska
city: Brick
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Skillman
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Liverpool
country: United States
facility: Altana Pharma/Nycomed
state: New York
city: Raleigh
country: United States
facility: Altana Pharma/Nycomed
state: North Carolina
city: Canton
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Cincinnati, OH
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Sylvania
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Medford
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Portland
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Easton
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Hershey
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Upland
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Charleston
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Charleston
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Moncks Corner
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Spartanburg
country: United States
facility: Altana Pharma/Nycomed
state: South Carolina
city: Austin
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: El Paso
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Fort Worth
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Friendswood
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Houston
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Katy
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: Richmond
country: United States
facility: Altana Pharma/Nycomed
state: Virginia
city: Richmond
country: United States
facility: Altana Pharma/Nycomed
state: Virginia
city: Spokane
country: United States
facility: Altana Pharma/Nycomed
state: Washington
city: Hamilton, ON
country: Canada
facility: Altana Pharma/Nycomed
city: Hamilton
country: Canada
facility: Altana Pharma/Nycomed
city: Kanata, ON
country: Canada
facility: Altana Pharma/Nycomed
city: London,ON
country: Canada
facility: Altana Pharma/Nycomed
city: London
country: Canada
facility: Altana Pharma/Nycomed
city: Mississauga
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal, QC
country: Canada
facility: Altana Pharma/Nycomed
city: Niagara Falls
country: Canada
facility: Altana Pharma/Nycomed
city: Oshawa, ON
country: Canada
facility: Altana Pharma/Nycomed
city: Ottawa, ON
country: Canada
facility: Altana Pharma/Nycomed
city: Ottawa
country: Canada
facility: Altana Pharma/Nycomed
city: Saskatoon,SK
country: Canada
facility: Altana Pharma/Nycomed
city: Ste-Foy PQ
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto, ON
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Winnipeg
country: Canada
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: