Clinical trial NCT00163501: Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
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: 600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Main Exclusion Criteria:

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
* Use of any prohibited concomitant medications as defined by the study protocol

Primary outcomes:
measure: change in Total Nasal Symptom Scores.
Secondary outcomes:
measure: change in symptoms, quality of life, safety.
Other outcomes:
Locations:
city: Encinitas
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 Angeles
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: San Diego
country: United States
facility: Altana Pharma/Nycomed
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Stockton
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Vista
country: United States
facility: Altana Pharma/Nycomed
state: California
city: Trumbull
country: United States
facility: Altana Pharma/Nycomed
state: Connecticut
city: Clearwater
country: United States
facility: Altana Pharma/Nycomed
state: Florida
city: Deland
country: United States
facility: Altana Pharma/Nycomed
state: Florida
city: Atlanta
country: United States
facility: Altana Pharma/Nycomed
state: Georgia
city: Normal
country: United States
facility: Altana Pharma/Nycomed
state: Illinois
city: Overland Park
country: United States
facility: Altana Pharma/Nycomed
state: Kansas
city: New Orleans
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: Forked River
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Skillman
country: United States
facility: Altana Pharma/Nycomed
state: New Jersey
city: Springfield
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: Winston-Salem
country: United States
facility: Altana Pharma/Nycomed
state: North Carolina
city: Cincinnati
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Cincinnati
country: United States
facility: Altana Pharma/Nycomed
state: Ohio
city: Oklahoma
country: United States
facility: Altana Pharma/Nycomed
state: Oklahoma
city: Portland
country: United States
facility: Altana Pharma/Nycomed
state: Oregon
city: Easton
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Altana Pharma/Nycomed
state: Pennsylvania
city: Cranston
country: United States
facility: Altana Pharma/Nycomed
state: Rhode Island
city: Austin
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Dallas
country: United States
facility: Altana Pharma/Nycomed
state: Texas
city: Houston
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: 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: