Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Beclomethasone dipropionate; Placebo Nasal Aerosol
Intervention description: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 30-weeks (or 52-weeks, depending upon investigator site).; Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).
Intervention MeSH terms: Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 529.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Rhinitis, Allergic, Perennial; BDP-HFA; Hay fever; Allergic rhinitis

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 be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA
      is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be
      safe and effective as a "dry" nasal aerosol which may be preferred by some patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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