This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
401
MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days.
Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days
Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.
The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
Time frame: Average of the last 7 days of treatment
Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.
Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.
Time frame: 29 days
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