Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis

Completed

Conditions studied: Perennial Allergic Rhinitis (PAR)

In brief

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.

Key facts

Study ID

NCT01632540

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

824

Starts

2012-07-01

Expected to finish

2014-02-01

Last updated by the study team

2014-04-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Teva Investigational Site 024 — Little Rock, Alaska, United States
• Teva Investigational Site 028 — Phoenix, Arizona, United States
• Teva Investigational Site 003 — Encinitas, California, United States
• Teva Investigational Site 042 — Fresno, California, United States
• Teva Investigational Site 006 — Los Angeles, California, United States
• Teva Investigational Site 017 — Orange, California, United States
• Teva Investigational Site 007 — Palmdale, California, United States
• Teva Investigational Site 021 — Paramount, California, United States
• Teva Investigational Site 040 — Redwood City, California, United States
• Teva Investigational Site 014 — Tallahassee, Florida, United States
• Teva Investigational Site 010 — Tamarac, Florida, United States
• Teva Investigational Site 038 — Albany, Georgia, United States
• Teva Investigational Site 031 — Lawrenceville, Georgia, United States
• Teva Investigational Site 035 — Savannah, Georgia, United States
• Teva Investigational Site 043 — Fort Mitchell, Kentucky, United States
• Teva Investigational Site 034 — Owensboro, Kentucky, United States
• Teva Investigational Site 033 — Mandeville, Louisiana, United States
• Teva Investigational Site 004 — Bethesda, Maryland, United States
• Teva Investigational Site 037 — Novi, Michigan, United States
• Teva Investigational Site 026 — Omaha, Nebraska, United States
• Teva Investigational Site 002 — Brick, New Jersey, United States
• Teva Investigational Site 019 — Corning, New York, United States
• Teva Investigational Site 018 — New York, New York, United States
• Teva Investigational Site 039 — Niagara Falls, New York, United States
• Teva Investigational Site 011 — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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