Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)

The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Inclusion Criteria:

• Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen
• Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year.
• Must be free of any clinically significant disease other than seasonal allergic rhinitis.
• Must be pre-menarcheal.

Exclusion Criteria:

• History of asthma which requires chronic use of inhaled or systemic corticosteroids.
• Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
• History of rhinitis medicamentosa.
• History of clinically significant nasal candidiasis.
• History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines.
• History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening.
• History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow.
• History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines.
• History of investigational drug use in the last 30 days.
• History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.