MOMETASONE FUROATE INTRA NASAL SPRAY FOR THE TREATMENT OF BILATERAL NASAL POLYPOSIS
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Abstract
Objective: To know the safety and efficacy of Topical mometasone furoate nasal spray (NS) for the treatment of bilateral
nasal polyposis..
Material and Methods: It was a randomized, double-blind, placebo controlled, parallel-group study, conducted in the
department of Otorhinolaryngology (Rhinology division) of Khyber Teaching Hospital, Peshawar-Pakistan. A total of
310 subjects 18 years or older with bilateral nasal polyps. Interventions: (1) A 200-?g dose of mometasone furoate NS
in the morning and matching placebo in the evening; (2) 200-?g doses of mometasone furoate NS in the morning and
evening; or (3) matching placebo in the morning and evening. All 3 regimens were administered as a nasal spray for 4
months, from September 2018 to December 2018.Primary end points were change from baseline to last assessment in
physician assessed bilateral polyp grade and change from baseline in subject-assessed congestion and/or obstruction
score averaged over the first month of treatment. Analysis of variance was used for all efficacy end points except for
change in bilateral polyp grade, for which baseline polyp grade was added as a covariate to the analysis of variance
model to account for any between-group baseline differences in this variable.
Results: Mometasone furoate NS doses of 200 ?g administered once or twice daily produced greater reductions in
bilateral polyp grade at the end point than placebo, with differences reaching statistical significance with twice daily
dosing (P=.04). Over 1 month, both mometasone furoate NS regimens produced statistically superior improvements
from baseline in congestion and/or obstruction score vs placebo (P=.01 for once-daily dosing; P.001 for twice daily
dosing). The drug was well tolerated.
Conclusion: Mometasone furoate NS is an effective and well-tolerated treatment for bilateral nasal polyposis in adults,
reducing nasal polyp size and symptoms of nasal congestion and/or obstruction.
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