Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis (BALANCE)
|ClinicalTrials.gov Identifier: NCT01632540|
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : April 15, 2014
|Condition or disease||Intervention/treatment|
|Perennial Allergic Rhinitis (PAR)||Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||824 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients|
|Study Start Date :||July 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||February 2014|
|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 Name: QNASL
- Change in Rhinitis Control Assessment Test (RCAT) Score [ Time Frame: Baseline and 6 months ]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.
- Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score [ Time Frame: Baseline and 6 months ]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.
- Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score [ Time Frame: Baseline and 6 months ]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.
- Change in the Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: Baseline and 6 months ]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.
- Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score [ Time Frame: Baseline and 6 months ]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.
- Change in overall healthcare utilization [ Time Frame: Baseline and 6 months ]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.
- Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR) [ Time Frame: Baseline and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632540
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|Principal Investigator:||Mark Lepore, MD||Teva Pharmaceutical Industries, Ltd.|