Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone Furoate (MF); Beclomethasone Dipropionate (BDP); Placebo
Intervention description: Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks.; Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) [336 mcg total dose per day] for 4 weeks.; Placebo nasal spray administered for 4 weeks.
Intervention MeSH terms: Mometasone Furoate; Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 345.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to determine the safety and efficacy in seasonal allergic
      rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate
      or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nonpregnant women of childbearing potential must be using a medically acceptable form
             of birth control for at least 3 months prior to Screening, and must continue its use
             for the duration of the study. Women not of childbearing potential must be surgically
             sterilized or at least one year post menopausal, or be otherwise incapable of bearing
             children

          -  2-year history of seasonal allergic rhinitis

          -  Positive skin test response to a local seasonal allergen within last 2 years

          -  Good health and free of any unstable, clinically significant disease, other than
             allergic rhinitis, that would interfere with the study schedule or evaluation of
             seasonal allergic rhinitis

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Women of childbearing potential who are not using an acceptable form of birth control

          -  Pre-menarchal females

          -  Asthma requiring therapy with inhaled or systemic corticosteroids

          -  Significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic,
             cerebrovascular, respiratory, gastrointestinal, or other significant medical illness
             or disorder which, in the judgment of the investigator, may interfere with the study,
             or require treatment which might interfere with the study

          -  On immunotherapy (unless maintenance therapy)

          -  Upper respiratory tract or sinus infection that requires antibiotic therapy within the
             previous 2 weeks

          -  Use of any investigational drug within the previous 90 days unless the investigational
             drug is a nasal corticosteroid or has a short (12 hours or less) duration of action,
             in which case the washout period will be 30 days

          -  Large nasal polyps, marked septal deviations or any other nasal structural abnormality
             that significantly interferes with nasal air flow

          -  Allergy to corticosteroids, or a history of multiple drug allergies

          -  History of posterior subcapsular cataracts

          -  Dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis
             medicamentosa

          -  Chronic use of any medication which could affect the course of seasonal allergic
             rhinitis

          -  Clinically significant abnormal electrocardiogram (ECG)