Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis (BALANCE)
This study is currently recruiting participants.
Verified April 2013 by Teva Pharmaceutical Industries
Sponsor:
Teva Pharmaceutical Industries
Collaborator:
United BioSource Corporation
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01632540
First received: June 28, 2012
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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 | Intervention |
|---|---|
|
Perennial Allergic Rhinitis (PAR) |
Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol |
| Study Type: | Observational [Patient Registry] |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Change in Rhinitis Control Assessment Test (RCAT) Score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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:
- Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632540
Show 45 Study Locations
Contacts
| Contact: Teva US Medical Information | 800-896-5855 |
Show 45 Study LocationsSponsors and Collaborators
Teva Pharmaceutical Industries
United BioSource Corporation
Investigators
| Principal Investigator: | Mark Lepore, MD | Teva Pharmaceutical Industries |
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT01632540 History of Changes |
| Other Study ID Numbers: | BDP-AR-401 |
| Study First Received: | June 28, 2012 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Beclomethasone Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013