A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Nasal Polyps (Protocol No. P05604)
Overview
- Phase
- Phase 3
- Intervention
- Mometasone Furoate Nasal Spray (MFNS)
- Conditions
- Nasal Polyps
- Sponsor
- Organon and Co
- Enrollment
- 748
- Primary Endpoint
- Change From Baseline in Congestion/Obstruction Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be Chinese
- •Must have a diagnosis of bilateral nasal polyps
- •Clinically significant nasal congestion/obstruction must be present
- •Must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromise the participant's safety
- •Must have negative urine pregnancy test
- •Must be using or agree to use a medically accepted method of contraception prior to Screening and during the study
Exclusion Criteria
- •Have a history of seasonal allergic rhinitis within the last two years
- •Have had sinus or nasal surgery within the past six months
- •Have presumed fibrotic nasal polyps
- •Have had three or more nasal surgeries
- •Have had any surgical procedure that prevents an accurate grading of the polyps
- •Complete (or near complete) nasal obstruction
- •Have acute sinusitis, concurrent nasal infection or have had a nasal infection within two weeks
- •Have ongoing rhinitis medicamentosa
- •Have Churg Strauss syndrome (vasculitis, asthma, fever, and eosinophilia)
- •Have dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immobile cilia)
Arms & Interventions
Mometasone Furoate Nasal Spray (MFNS)
Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
Intervention: Mometasone Furoate Nasal Spray (MFNS)
Placebo
Participants receive matching placebo nasal spray BID for 16 weeks
Intervention: Placebo for MFNS
Outcomes
Primary Outcomes
Change From Baseline in Congestion/Obstruction Score
Time Frame: Baseline and Weeks 1-4
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.
Change From Baseline in Total Polyp Size Score
Time Frame: Baseline and Week 16
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.