Beclomethasone Dipropionate (BDP) Nasal Aerosol
DrugBDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
Other names: QNASL
NCT Number: NCT01632540
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.
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Notify Me12 year and older
All sexes
Observational
Teva Investigational Site 024, Little Rock, Alaska, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
Other names: QNASL
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.
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.
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.
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.
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.
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.
Time frame: Baseline and 6 months
Teva Branded Pharmaceutical Products R&D, Inc.
Industry
Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients
Acronym: BALANCE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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