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 Type
OBSERVATIONAL
Enrollment
824
BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
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.
Time frame: Baseline and 6 months
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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Teva Investigational Site 024
Little Rock, Alaska, United States
Teva Investigational Site 028
Phoenix, Arizona, United States
Teva Investigational Site 003
Encinitas, California, United States
Teva Investigational Site 042
Fresno, California, United States
Teva Investigational Site 006
Los Angeles, California, United States
Teva Investigational Site 017
Orange, California, United States
Teva Investigational Site 007
Palmdale, California, United States
Teva Investigational Site 021
Paramount, California, United States
Teva Investigational Site 040
Redwood City, California, United States
Teva Investigational Site 014
Tallahassee, Florida, United States
...and 36 more locations
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months
Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR)
Time frame: Baseline and 6 months