Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
Condition: Seasonal Allergic Rhinitis; Hayfever
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Beclomethasone dipropionate HFA Nasal Aerosol; Placebo
Intervention description: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol; HFA Vehicle Aerosol
Intervention MeSH terms: Beclomethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 487.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Seasonal Allergic Rhinitis; Hayfever

Summary:

      This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week,
      multi-center, dose-range-finding study in male or female patients (12 years and older) with
      SAR.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female patients 12 years of age and 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 patient at increased risk during the study.

          -  A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of
             two years immediately preceding the study Screening Visit (SV). The SAR 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 be exposed to the
             allergen and require treatment throughout the entire study period.

          -  A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through
             a standard skin prick test. A positive test is defined as a wheal diameter at least 3
             mm larger than the control wheal for the skin prick test. Documentation of a positive
             result within 12 months prior to Screening Visit (SV) is acceptable.

          -  Other criteria apply

        Key Exclusion Criteria:

          -  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 physical findings of nasal pathology, including nasal polyps or other
             clinically significant respiratory tract malformations, recent nasal biopsy, nasal
             trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last
             60 days prior to the SV).

          -  History of a respiratory infection or disorder [including, but not limited to
             bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome
             (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a
             respiratory infection during the Run-in Period.

          -  Use of any prohibited concomitant medications within the prescribed (per protocol)
             time since the last dosing period prior to the Screening Visit (SV) and/or plans for
             use during the entire treatment duration.

          -  Other criteria apply