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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632540
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : April 15, 2014
United BioSource Corporation
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Brief 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.

Condition or disease Intervention/treatment
Perennial Allergic Rhinitis (PAR) Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol

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Study Type : Observational [Patient Registry]
Actual Enrollment : 824 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

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 Name: QNASL

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR) [ Time Frame: Baseline and 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632540

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Sponsors and Collaborators
Teva Pharmaceutical Industries
United BioSource Corporation
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Principal Investigator: Mark Lepore, MD Teva Pharmaceutical Industries, Ltd.

Additional Information:

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Responsible Party: Teva Pharmaceutical Industries Identifier: NCT01632540    
Other Study ID Numbers: BDP-AR-401
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents