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NCT01632540 Clinical Trial

Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis

Perennial Allergic Rhinitis (PAR) Clinical Trial

— BALANCE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01632540
Other study ID # BDP-AR-401
Secondary ID
Status Completed
Phase N/A
First received June 28, 2012
Last updated April 14, 2014
Start date July 2012
Est. completion date February 2014

Study information
Verified date April 2014
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial 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.

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Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.
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Sponsors (2)
Lead Sponsor Collaborator
Teva Pharmaceutical Industries United BioSource Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR) Baseline and 6 months No
See also
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