Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray; Placebo
Intervention description: Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning; Two sprays in each nostril in the morning
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 429.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS)
      once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in
      reducing the total 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). 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 ECG results. Clinical laboratory test (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.

          -  A subject and/or a parent/guardian must be willing to give written informed consent
             and must be able to adhere to dosing and visit schedules and meet study requirements.

          -  A female subject of childbearing potential must have a negative serum pregnancy test
             (HCG) at Screening. Nonsterile and premenopausal female subjects must be using a
             medically acceptable method of birth control, ie, double barrier method, oral
             contraceptive, hormonal implant, or depot injectable prior to Screening and during the
             study.

        Exclusion Criteria:

          -  A history of anaphylaxis and/or other severe local reaction(s) to skin testing.

          -  A subject with asthma who require 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 have 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 have 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.

          -  Use of any drug in an investigational protocol in the 30 days before the Screening
             Visit.

          -  A subject on immunotherapy (desensitization therapy), unless the subject is on a
             regular maintenance schedule prior to the Screening Visit and will stay on this
             schedule for the remainder of the study. A subject may not receive desensitization
             treatment within 24 hours before any visit.

          -  Pregnant or nursing females.

          -  Family member of the investigation study staff.

          -  Current evidence of clinically significant hematopoietic, cardiovascular, hepatic,
             renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes
             the subject's participation in the study. Particular attention should be given to
             exclude subjects with conditions that would currently interfere with the absorption,
             distribution, metabolism, or excretion of the study drug or interfere with the
             subject's ability to complete or reliably complete the diaries.

          -  Significant medical condition(s) that, in the judgment of the investigator, might
             interfere with the study or require treatment.

          -  A subject whose ability to provide informed consent is compromised.

          -  A subject with a history of noncompliance with medications or treatment

        protocols.