This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)

This is an interventional treatment trial for Seasonal Allergic Rhinitis Read More

Inclusion Criteria:

• Willing to participate and to adhere to dose and visit schedules
• 18 to 65 years, either sex, any race
• 2-year history of SAR, being symptomatic during the last 2 ragweed seasons
• Skin test positive to short ragweed allergen at screening, or positive within 12 months
• Women must practice adequate contraception: Females of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.; Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation)
• Negative pregnancy tests during study

Exclusion Criteria:

• Compromised ability to provide informed consent
• Nasal abnormalities, including large nasal polyps, and marked septum deviation that interferes with nasal airflow at screening
• Recent (within the last 2 weeks) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma
• Unstable asthma which cannot be controlled with inhaled short-acting beta-2 agonists
• Diagnosed with sinusitis within the previous 2 weeks
• Is initiating or is currently on advanced immunotherapy
• If on immunotherapy (desensitization therapy), the subject must be stable and should not receive an increase in dose during the study. Subjects may not receive desensitization treatment within 24 hours prior to a study visit
• Is currently on or has been on an antihistamine, decongestant (topical or systemic) or a nasal inhaled corticosteroid during the 14 days prior to the first priming visit
• Unable to refrain from regular use of nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
• Failed the designated washout periods for any of the prohibited medications
• Upper or lower respiratory tract or sinus infection that required antibiotic therapy or a viral upper or lower respiratory infection within 14 days prior to screening
• Is allergic to or has sensitivity to the study drug or its excipients
• Used any investigational product within 30 days before enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days
• Subject has Chronic obstructive pulmonary disease, Alcohol abuse, Rhinitis medicamentosa