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)

Organon

Status and phase

Completed

Phase 4

Conditions

Seasonal Allergic Rhinitis

Treatments

Other: Placebo

Drug: Mometasone Furoate Nasal Spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT00491504

P05073

Details and patient eligibility

About

The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.

Enrollment

310 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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