This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
748
MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks
Two sprays in each nostril BID for up to 16 weeks
Change From Baseline in Congestion/Obstruction Score
At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.
Time frame: Baseline and Weeks 1-4
Change From Baseline in Total Polyp Size Score
An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.
Time frame: Baseline and Week 16
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