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

Teva Pharmaceuticals

Status: Completed

Conditions: Perennial Allergic Rhinitis (PAR)

Treatments: Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol

Study type: Observational

Funder types: Industry

Identifiers

NCT01632540

BDP-AR-401

Details and patient eligibility

About

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.

Enrollment: 824 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

824 participants in 1 patient group

Perennial Allergic Rhinitis patients

Treatment:

Drug: Beclomethasone Dipropionate (BDP) Nasal Aerosol