Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
Condition: Seasonal Allergic Rhinitis; SAR
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Hypersensitivity
Intervention: BDP HFA; Placebo nasal aerosol
Intervention description: BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.; Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.
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: 715.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Allergies; Hayfever

Summary:

      The purpose of this study is to assess the safety and efficacy of an investigational nasal
      aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal
      allergic rhinitis in children (6-11 years of age).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)

          -  A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a
             minimum of two years immediately preceding the study Screening Visit (SV).

          -  A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known
             to induce SAR through a standard skin prick test.

          -  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 (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa
             (all within the last 60 days prior to the Screening Visit [SV])

          -  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 beta-agonists and any controller drug (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

          -  Have any conditions that are judged by the investigator to be clinically significant
             and/or affect the subject's ability to participate in the clinical trial

          -  Other criteria apply