A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)

Phase 3 Completed 748 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.

Timeline

Start: 2011-06
Primary completion: 2013-02
Completion: 2013-02

Outcome

Met primary endpoint

registry analysis (unspecified test); MFNS vs Placebo; p = 0.0007; Difference in LS Means -0.14 (95% CI -0.22 to -0.06); ANCOVA NCT01386125 ↗

registry analysis (unspecified test); MFNS vs Placebo; p <0.0001; Difference is LS Means -0.30 (95% CI -0.45 to -0.15); Constrained longitudinal data analysis NCT01386125 ↗

Publications

Results Zhou B, He G, Liang J, Cheng L, Mehta A, Liu S, Yu W, Wang Z, Han D. Mometasone furoate nasal spray in the treatment of nasal polyposis in Chinese patients: a double-blind, randomized, placebo-controlled trial. Int Forum Allergy Rhinol. 2016 Jan;6(1):88-94. doi: 10.1002/alr.21650. Epub 2015 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mometasone furoate	Other / unclassified	200 ug	Intranasal