Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: mometasone furoate; Placebo
Intervention description: 50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning; Two sprays in each nostril once daily in the morning
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 426.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS)
      once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in
      reducing the total nasal symptom score and the total ocular symptom score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 12 years of age or older, of either sex and of any race.

          -  Must have at least a 2-year documented history of SAR which exacerbates during the
             study season.

          -  Must have a positive skin-prick test response to an appropriate seasonal allergen at
             Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an
             appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented
             by a positive response to the skin prick test with wheal diameter at least 3 mm larger
             than diluent control after 20 minutes.

          -  Must be clinically symptomatic at the Screening Visit.

          -  Must be clinically symptomatic at the Baseline Visit.

          -  Must be in general good health as confirmed by routine clinical and laboratory testing
             and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count
             [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically
             acceptable to the investigator and the sponsor.

          -  Must be free of any clinically significant disease, other than SAR, that would
             interfere with the study evaluations.

        Exclusion Criteria:

          -  A history of anaphylaxis and/or other severe local reaction(s) to skin testing.

          -  A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.

          -  Current or history of frequent, clinically significant sinusitis or chronic purulent
             postnasal drip.

          -  A subject with rhinitis medicamentosa.

          -  A history of allergies to more than two classes of medications or who are allergic to
             or cannot tolerate nasal sprays.

          -  A subject who has had an upper respiratory tract or sinus infection that required
             antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or
             who has had a viral upper respiratory infection within 7 days before the Screening
             Visit.

          -  A subject who has nasal structural abnormalities, including large nasal polyps and
             marked septal deviations, which significantly interfere with nasal air flow.

          -  A subject who, in the opinion of the investigator, is dependent on nasal, oral, or
             ocular decongestants, nasal topical antihistamines, or nasal steroids.