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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.


Recruitment information / eligibility

Status Completed
Enrollment 824
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

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.

Locations

Country Name City State
United States Teva Investigational Site 038 Albany Georgia
United States Teva Investigational Site 022 Ashland Oregon
United States Teva Investigational Site 004 Bethesda Maryland
United States Teva Investigational Site 002 Brick New Jersey
United States Teva Investigational Site 019 Corning New York
United States Teva Investigational Site 015 Dallas Texas
United States Teva Investigational Site 029 Dallas Texas
United States Teva Investigational Site 003 Encinitas California
United States Teva Investigational Site 016 Eugene Oregon
United States Teva Investigational Site 043 Fort Mitchell Kentucky
United States Teva Investigational Site 009 Fort Worth Texas
United States Teva Investigational Site 042 Fresno California
United States Teva Investigational Site 036 Greenfield Wisconsin
United States Teva Investigational Site 032 Havertown Pennsylvania
United States Teva Investigational Site 011 High Point North Carolina
United States Teva Investigational Site 020 Houston Texas
United States Teva Investigational Site 031 Lawrenceville Georgia
United States Teva Investigational Site 024 Little Rock Alaska
United States Teva Investigational Site 006 Los Angeles California
United States Teva Investigational Site 033 Mandeville Louisiana
United States Teva Investigational Site 005 Murray Utah
United States Teva Investigational Site 018 New York New York
United States Teva Investigational Site 045 Newport News Virginia
United States Teva Investigational Site 039 Niagara Falls New York
United States Teva Investigational Site 025 Normal Pennsylvania
United States Teva Investigational Site 037 Novi Michigan
United States Teva Investigational Site 026 Omaha Nebraska
United States Teva Investigational Site 017 Orange California
United States Teva Investigational Site 034 Owensboro Kentucky
United States Teva Investigational Site 007 Palmdale California
United States Teva Investigational Site 021 Paramount California
United States Teva Investigational Site 028 Phoenix Arizona
United States Teva Investigational Site 012 Pittsburgh Pennsylvania
United States Teva Investigational Site 008 Puyallup Washington
United States Teva Investigational Site 040 Redwood City California
United States Teva Investigational Site 041 San Antonio Texas
United States Teva Investigational Site 044 San Antonio Texas
United States Teva Investigational Site 046 San Antonio Texas
United States Teva Investigational Site 035 Savannah Georgia
United States Teva Investigational Site 014 Tallahassee Florida
United States Teva Investigational Site 010 Tamarac Florida
United States Teva Investigational Site 013 Toledo Ohio
United States Teva Investigational Site 023 Upland Pennsylvania
United States Teva Investigational Site 001 Waco Texas
United States Teva Investigational Site 027 Winston-Salem North Carolina
United States Teva Investigational Site 030 Winston-Salem North Carolina

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
  Status Clinical Trial Phase
Recruiting NCT06339008 - A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1) Phase 3