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

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)

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

Study Overview

• Status: Completed
• Conditions: Nasal Polyps
• Intervention / Treatment: Drug: Mometasone Furoate Nasal Spray (MFNS); Drug: Placebo for MFNS

• Study Type: Interventional
• Enrollment (Actual): 748
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)
• Have been treated within the last 4 weeks with intranasal steroids
• Have used any investigational drug in the last 30 days
• Have a hypersensitivity to corticosteroids or are allergic to aspirin
• Have an ongoing upper respiratory tract infection or had an upper respiratory tract infection within two weeks
• Have a nasal septal deviation needing corrective surgery
• Have a nasal septal perforation
• Have asthma that required in-patient hospitalization for asthma control within six months, required ventilator support for respiratory failure secondary to their asthma within the last five years, required admission to the hospital for management of airway obstruction on two or more occasions within the past year, or required use of more than 14 days of systemic steroid use in previous six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mometasone Furoate Nasal Spray (MFNS); Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks	Drug: Mometasone Furoate Nasal Spray (MFNS); MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks
Placebo Comparator: Placebo; Participants receive matching placebo nasal spray BID for 16 weeks	Drug: Placebo for MFNS; Two sprays in each nostril BID for up to 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and Week 16

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Nasal Polyps; Polyps; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P05604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php