Clinical trial NCT01632540: Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis
Official title: Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perennial Allergic Rhinitis (PAR)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United BioSource, LLC
First posted: 2012-07-03
Enrollment: 824
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients, at least 12 years of age, with a diagnosis of PAR for at least one year and who are newly prescribed BDP nasal aerosol.

Brief summary: This study will be a prospective observational study of "real world" BDP nasal aerosol users with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly online surveys regarding rhinitis control, concomitant medical conditions, concomitant (non-AR) medications, current AR therapy, and adverse events.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 12 years or greater at time of enrollment
* Diagnosis of PAR for at least one year; and 2)a positive skin prick (ie, epicutaneous) or serum-specific IgE test within the past 2 years to a perennial allergen as appropriate for the location; and 3)PAR symptoms that are consistent with exposure to this allergen for at least one year
* Uncontrolled rhinitis symptoms at the time of assessment as confirmed by a score of 21 or less on the RCAT
* Newly prescribed BDP Nasal Aerosol (within the past 7 days but have not yet used)
* Willing and able to complete surveys in English on a computer with internet access
* Willing and able to provide informed consent prior to entering the study (or parent/caregiver/legal guardian if applicable)

Exclusion Criteria:

* Current acute or chronic sinusitis or chronic purulent nasal discharge
* Rhinitis medicamentosa or nasal structural abnormalities (including nasal polyps and clinically significant septal deviation) that significantly interfere with nasal airflow
* Acute upper respiratory infection within the past 14 days
* Used any pressurized metered-dose inhaler INS product (including BDP Nasal Aerosol and Ciclesonide Nasal Aerosol) within the past 90 days
* Used any experimental therapy for AR within the past 30 days
* Any condition which the investigator feels may interfere with the study

Primary outcomes:
measure: Change in Rhinitis Control Assessment Test (RCAT) Score
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score
timeFrame: Baseline and 6 months
measure: Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score
timeFrame: Baseline and 6 months
measure: Change in the Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: Baseline and 6 months
measure: Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score
timeFrame: Baseline and 6 months
measure: Change in overall healthcare utilization
timeFrame: Baseline and 6 months
measure: Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Teva Investigational Site 024
state: Alaska
city: Phoenix
country: United States
facility: Teva Investigational Site 028
state: Arizona
city: Encinitas
country: United States
facility: Teva Investigational Site 003
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 042
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 006
state: California
city: Orange
country: United States
facility: Teva Investigational Site 017
state: California
city: Palmdale
country: United States
facility: Teva Investigational Site 007
state: California
city: Paramount
country: United States
facility: Teva Investigational Site 021
state: California
city: Redwood City
country: United States
facility: Teva Investigational Site 040
state: California
city: Tallahassee
country: United States
facility: Teva Investigational Site 014
state: Florida
city: Tamarac
country: United States
facility: Teva Investigational Site 010
state: Florida
city: Albany
country: United States
facility: Teva Investigational Site 038
state: Georgia
city: Lawrenceville
country: United States
facility: Teva Investigational Site 031
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 035
state: Georgia
city: Fort Mitchell
country: United States
facility: Teva Investigational Site 043
state: Kentucky
city: Owensboro
country: United States
facility: Teva Investigational Site 034
state: Kentucky
city: Mandeville
country: United States
facility: Teva Investigational Site 033
state: Louisiana
city: Bethesda
country: United States
facility: Teva Investigational Site 004
state: Maryland
city: Novi
country: United States
facility: Teva Investigational Site 037
state: Michigan
city: Omaha
country: United States
facility: Teva Investigational Site 026
state: Nebraska
city: Brick
country: United States
facility: Teva Investigational Site 002
state: New Jersey
city: Corning
country: United States
facility: Teva Investigational Site 019
state: New York
city: New York
country: United States
facility: Teva Investigational Site 018
state: New York
city: Niagara Falls
country: United States
facility: Teva Investigational Site 039
state: New York
city: High Point
country: United States
facility: Teva Investigational Site 011
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 027
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 030
state: North Carolina
city: Toledo
country: United States
facility: Teva Investigational Site 013
state: Ohio
city: Ashland
country: United States
facility: Teva Investigational Site 022
state: Oregon
city: Eugene
country: United States
facility: Teva Investigational Site 016
state: Oregon
city: Havertown
country: United States
facility: Teva Investigational Site 032
state: Pennsylvania
city: Normal
country: United States
facility: Teva Investigational Site 025
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 012
state: Pennsylvania
city: Upland
country: United States
facility: Teva Investigational Site 023
state: Pennsylvania
city: Dallas
country: United States
facility: Teva Investigational Site 015
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 029
state: Texas
city: Fort Worth
country: United States
facility: Teva Investigational Site 009
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 020
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 041
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 044
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 046
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 001
state: Texas
city: Murray
country: United States
facility: Teva Investigational Site 005
state: Utah
city: Newport News
country: United States
facility: Teva Investigational Site 045
state: Virginia
city: Puyallup
country: United States
facility: Teva Investigational Site 008
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 036
state: Wisconsin
Study officials:
affiliation: Teva Pharmaceutical Industries, Ltd.
name: Mark Lepore, MD
role: PRINCIPAL_INVESTIGATOR
References: