Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY); OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY); mometasone furoate nasal spray (MFNS) once daily; oxymetazoline nasal spray (OXY) twice daily; Placebo
Intervention description: MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).; MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.; MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.; OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.; Matching placebo to MFNS given every morning and every evening x 2 weeks.
Intervention MeSH terms: Mometasone Furoate; Phenylephrine; Oxymetazoline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 707.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of the combination of
      mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once
      a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms
      including nasal congestion. The secondary objectives of this study are to evaluate the
      potential of the combination to produce tachyphylaxis and/or rebound congestion, and to
      evaluate the safety of the combination.
    

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
             time period over which the subject will be participating.

          -  Must have a documented (within the past 12 months) positive skin-prick test response
             to an appropriate seasonal allergen appropriate to the geographical vicinity in which
             the study is being carried out and over the period of time the subject is
             participating.

          -  Must be clinically symptomatic at the Screening and Baseline Visits.

          -  Must be in general good health as confirmed by routine clinical and laboratory testing
             and electrocardiogram results.

          -  Must be free of any clinically significant disease, other than SAR, which would
             interfere with the study evaluations.

          -  Must be willing to give written informed consent and must be able to adhere to dosing
             and visit schedules and study requirements.

          -  Female subjects of child-bearing potential must have a negative serum pregnancy test
             at screening. Nonsterile and premenopausal female subjects must be using a medically
             acceptable method of birth control prior to screening and during the entire study.

          -  Must have the ability to transmit electronic diary data on a regular basis.

        Exclusion Criteria:

          -  A subject with 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.

          -  A subject with current or history of frequent, clinically significant sinusitis or
             chronic purulent postnasal drip.

          -  A subject with rhinitis medicamentosa.

          -  A subject with glaucoma and/or increased intraocular pressure.

          -  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.

          -  A pregnant or nursing female.

          -  A subject with current evidence of clinically significant hematopoietic,
             cardiovascular, hepatic, renal, neurologic, psychiatric, pulmonary, 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.