Status:
COMPLETED
Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will...
Eligibility Criteria
Inclusion
- Male or female subjects, 12 years of age or older as of the Screening Visit (SV)
- General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study
- A history of PAR to a relevant perennial allergen for a minimum of two years immediately preceding the study Screening Visit (SV). The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and in the investigator's judgment is expected to require treatment throughout the entire study
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the diluent control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (SV) is acceptable
- Other criteria apply
Exclusion
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, including nasal piercing, or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to Screening Visit \[SV\])
- Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study
- History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis, or influenza within the 14 days preceding the Screening Visit (SV) or development of a respiratory infection during the Run-In Period
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists and any controller drugs (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable.
- Other criteria apply
- Randomization Criteria
- Subject continues to be in general good health, meeting the selection criteria
- Subject has a minimum subject-reported reflective TNSS of an average of 5 (out of a possible 12) on the last 7 days during the Run-In Period
- The subject-reported scores for rhinorrhea or nasal congestion must be an average of 2 or greater during the last 7 days of the Run-In Period
- Each subject must have adequately completed the electronic AR Assessment Diary (failure is defined as missing the diary entry on more than 2 calendar days during the last 7 days of the Run-In Period)
- Other criteria apply
Key Trial Info
Start Date :
October 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2011
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT00988247
Start Date
October 31 2009
End Date
February 28 2011
Last Update
December 3 2021
Active Locations (34)
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1
Teva Clinical Sudy Site
Oxford, Alabama, United States, 36203
2
Teva Clinical Study Site
Encinitas, California, United States, 92024
3
Teva Clinical Study Site
Huntington Beach, California, United States, 92647
4
Teva Clinical Study Site
San Diego, California, United States, 92120