Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis (BALANCE)

Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients

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.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis (PAR)
• Intervention / Treatment: Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol

• Study Type: Observational
• Enrollment (Actual): 824

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Little Rock, Alaska, United States
      • Teva Investigational Site 024
  • Arizona
    • Phoenix, Arizona, United States
      • Teva Investigational Site 028
  • California
    • Encinitas, California, United States
      • Teva Investigational Site 003
    • Fresno, California, United States
      • Teva Investigational Site 042
    • Los Angeles, California, United States
      • Teva Investigational Site 006
    • Orange, California, United States
      • Teva Investigational Site 017
    • Palmdale, California, United States
      • Teva Investigational Site 007
    • Paramount, California, United States
      • Teva Investigational Site 021
    • Redwood City, California, United States
      • Teva Investigational Site 040
  • Florida
    • Tallahassee, Florida, United States
      • Teva Investigational Site 014
    • Tamarac, Florida, United States
      • Teva Investigational Site 010
  • Georgia
    • Albany, Georgia, United States
      • Teva Investigational Site 038
    • Lawrenceville, Georgia, United States
      • Teva Investigational Site 031
    • Savannah, Georgia, United States
      • Teva Investigational Site 035
  • Kentucky
    • Fort Mitchell, Kentucky, United States
      • Teva Investigational Site 043
    • Owensboro, Kentucky, United States
      • Teva Investigational Site 034
  • Louisiana
    • Mandeville, Louisiana, United States
      • Teva Investigational Site 033
  • Maryland
    • Bethesda, Maryland, United States
      • Teva Investigational Site 004
  • Michigan
    • Novi, Michigan, United States
      • Teva Investigational Site 037
  • Nebraska
    • Omaha, Nebraska, United States
      • Teva Investigational Site 026
  • New Jersey
    • Brick, New Jersey, United States
      • Teva Investigational Site 002
  • New York
    • Corning, New York, United States
      • Teva Investigational Site 019
    • New York, New York, United States
      • Teva Investigational Site 018
    • Niagara Falls, New York, United States
      • Teva Investigational Site 039
  • North Carolina
    • High Point, North Carolina, United States
      • Teva Investigational Site 011
    • Winston-Salem, North Carolina, United States
      • Teva Investigational Site 027
    • Winston-Salem, North Carolina, United States
      • Teva Investigational Site 030
  • Ohio
    • Toledo, Ohio, United States
      • Teva Investigational Site 013
  • Oregon
    • Ashland, Oregon, United States
      • Teva Investigational Site 022
    • Eugene, Oregon, United States
      • Teva Investigational Site 016
  • Pennsylvania
    • Havertown, Pennsylvania, United States
      • Teva Investigational Site 032
    • Normal, Pennsylvania, United States
      • Teva Investigational Site 025
    • Pittsburgh, Pennsylvania, United States
      • Teva Investigational Site 012
    • Upland, Pennsylvania, United States
      • Teva Investigational Site 023
  • Texas
    • Dallas, Texas, United States
      • Teva Investigational Site 015
    • Dallas, Texas, United States
      • Teva Investigational Site 029
    • Fort Worth, Texas, United States
      • Teva Investigational Site 009
    • Houston, Texas, United States
      • Teva Investigational Site 020
    • San Antonio, Texas, United States
      • Teva Investigational Site 041
    • San Antonio, Texas, United States
      • Teva Investigational Site 044
    • San Antonio, Texas, United States
      • Teva Investigational Site 046
    • Waco, Texas, United States
      • Teva Investigational Site 001
  • Utah
    • Murray, Utah, United States
      • Teva Investigational Site 005
  • Virginia
    • Newport News, Virginia, United States
      • Teva Investigational Site 045
  • Washington
    • Puyallup, Washington, United States
      • Teva Investigational Site 008
  • Wisconsin
    • Greenfield, Wisconsin, United States
      • Teva Investigational Site 036

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perennial Allergic Rhinitis patients	Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol; BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.; Other Names: QNASL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rhinitis Control Assessment Test (RCAT) Score	The RCAT will be completed each month and uses a one-week recall period. This questionnaire has six items that ask about nasal and other allergy symptoms and the control of these symptoms. Each question is responded to on a scale of 1-5. The responses are summed to evaluate a total score. A higher score (22-30) indicates that symptoms are well controlled. A lower score (5-21) indicates that rhinitis symptoms are not well controlled.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score	The TSQM-9 asks patients about their level of satisfaction or dissatisfaction with the medication they are taking in the study. The 3 subscales (effectiveness, convenience, global satisfaction) are rated separately, and there is no overall score. 7 questions have responses ranging from 1=extremely dissatisfied/difficult/inconvenient to 7=extremely satisfied/easy/convenient. 2 questions have responses ranging from 1=not at all confident/certain to 5=extremely confident/certain. Higher scores indicate greater satisfaction with the medication.	Baseline and 6 months
Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score	The WPAI-CIQ-AS is a 9-item, patient-reported scale that asks about the amount of time lost from work or academic classes due to allergies, as well as the impact of allergies on performing work in the workplace or in school or attending classes. It also asks about the effect of allergies on other usual daily activities. All questions ask for recall of the last 7 days. Outcomes are expressed as impairment percentages, with higher scores indicating greater impairment and less productivity.	Baseline and 6 months
Change in the Pittsburgh Sleep Quality Index (PSQI) score	The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month interval. 19 items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction. The scores of these components yield a "global score". A global score of 5 or greater indicates a poor sleeper.	Baseline and 6 months
Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score	This 14-item scale covers 5 domains: activity limitations, practical problems, nose symptoms, eye symptoms, other symptoms. Responses range from 0=not troubled to 6=extremely troubled. 5 component scores and a global score are calculated. Higher scores indicate being more troubled as a result of nose/eye symptoms during the past week.	Baseline and 6 months
Change in overall healthcare utilization	Medical resources include in-patient care (hospitalizations, days of hospitalization), emergency room, and out-patient visits to physicians and other healthcare providers. The health services utilization survey asks for a 3 month recall and will be completed at baseline and months 3, 6, 9, and 12.	Baseline and 6 months
Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR)		Baseline and 6 months

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Collaborators: United BioSource, LLC
• Investigators: Principal Investigator: Mark Lepore, MD, Teva Pharmaceutical Industries, Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (ESTIMATE): July 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: BDP-AR-401