Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED)

Inclusion Criteria:

1. Must be 18 to 45 years of age, of either sex, and any race.

2. Must have at least a 2-year history of PAR.

3. Must be skin test positive for the usual allergens associated with PAR within theprevious 12 months with regular exposure to at least one of the allergens to which thesubject is allergic.

4. Must be sufficiently symptomatic at the Screening Visit (Visit 1), Qualification Visit (Visit 2), and Baseline Visit (Visit 4) with a minimal level of PRIOR (reflective)total symptom score, total nasal symptoms score, and total non-nasal symptoms score inorder to qualify.

5. At the Qualification Visit 2, subjects must have a score of at least 2 with theInterference with Sleep severity rating score for at least 3 of the 7 nights prior tothe Qualification visit.

6. At the Baseline Visit 4 subjects must have a score of at least 2 with the Interferencewith Sleep severity rating score for at least 1 of the 3 nights prior to the BaselineVisit.

7. Must have an apnea-hypopnea index (AHI) of >=5, but not more than 30, during the firstscreening polysomnographic evaluation and to proceed to the second polysomnographicevaluation.

8. At the Baseline Visit (Visit 4), the subjects must complete the NRQLQ, PQSI, ESS,WPAI-AS.

9. Must complete the PVT within 1 hour of bedtime and 1 hour of arising on the nightswhen the PSGs are done.

10. Female subjects of childbearing potential (including women who are less than 1 yearpostmenopausal and women who will be sexually active during the study) must agree touse a medically accepted method of contraception or be surgically sterilized prior toscreening, while receiving protocol-specified medication, and for 30 days afterstopping the medication. Women who are postmenopausal for >1 year (ie, women who haveexperienced 12 consecutive months of amenorrhea) will be exempted from the use ofcontraception during the study.

11. Female subjects of childbearing potential must have a negative urine pregnancy test atScreening (Visit 1) and a negative urine pregnancy test at Visit 4 confirmed prior todosing with the study drug and at final Visit 7.

Exclusion Criteria:

1. Subject has symptomatic seasonal allergic rhinitis (SAR) or a history of SAR duringthe same calendar period as this study.

2. Subject is a female who is pregnant, or intends to become pregnant during the study.

3. Subject is nursing, or intends to be nursing during the study.

4. Subject has used any investigational product within 30 days prior to enrollment or anyantibodies for asthma or allergic rhinitis in the past 90 days).

5. Subject has any of the following clinical conditions:

• known severe sleep apnea

• asthma

• chronic obstructive pulmonary disease (COPD)

• alcohol abuse

• rhinitis medicamentosa

6. Subject is currently on or has been on an antihistamine, decongestant (topical orsystemic) or a nasal inhaled corticosteroid during the 14 days prior to the ScreeningVisit.

7. Subject with current or history of frequent episodes (2 or more episodes per year forthe past 2 years) of clinically significant sinusitis or chronic purulent postnasaldrip.

8. Subject has had recent nasal septum ulcers, nasal surgery, or nasal trauma.

9. Subject has had an upper or lower respiratory tract or sinus infection that requiredantibiotic therapy with the last dose 14 days prior to screening, or who has had aviral upper or lower respiratory infection within 14 days prior to screening.

10. Subject has nasal structural abnormalities, including large nasal polyps, and markedseptum deviation that significantly interfere with nasal airflow.

11. Subject is unable to refrain from regular use of nasal, oral or ocular decongestants,nasal topical antihistamines, or nasal steroids.

12. Subject on immunotherapy (desensitization therapy) should not receive an increase indose during the study. Subjects may not receive desensitization treatment within 24hours prior to a study visit.

13. Subject has active or quiescent tuberculosis infection of the respiratory tract,untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex.

14. Subject is morbidly obese (BMI >=35).

15. Subject is a night-shift worker and does not have a standard asleep at night / awakeduring the day cycle, or has an irregular sleep/wake schedule.

16. Subject reports routinely spending less than 6 1/2 hours of time in bed per night.

17. Subject reports drinking 3 or more cups of regular coffee or 4 or more 8 ouncecans/bottles of caffeine-containing carbonated beverages per 24 hour period.