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Clinical Trials/NCT01632540
NCT01632540CompletedNot Applicable

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

Teva Branded Pharmaceutical Products R&D, Inc.46 sites in 1 country824 target enrollmentStarted: July 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
824
Locations
46
Primary Endpoint
Change in Rhinitis Control Assessment Test (RCAT) Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Perennial Allergic Rhinitis patients

Intervention: Beclomethasone Dipropionate (BDP) Nasal Aerosol (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) score(Baseline and 6 months)
  • Change in the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-specific (WPAI-CIQ-AS) score(Baseline and 6 months)
  • Change in the Pittsburgh Sleep Quality Index (PSQI) score(Baseline and 6 months)
  • Change in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score(Baseline and 6 months)
  • Change in overall healthcare utilization(Baseline and 6 months)
  • Change in number of non-intranasal corticosteroids (INS) medications for allergic rhinitis (AR)(Baseline and 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (46)

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