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

NCT01386125 | Completed Phase 3 Results

• 1 other identifier: P05604
• Study Type: interventional
• Target: 748
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Mometasone Furoate Nasal Spray (MFNS)

EXPERIMENTAL

Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks

Drug: Mometasone Furoate Nasal Spray (MFNS)

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo nasal spray BID for 16 weeks

Drug: Placebo for MFNS

Interventions

Mometasone Furoate Nasal Spray (MFNS) DRUG

MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks

Mometasone Furoate Nasal Spray (MFNS)

Placebo for MFNS DRUG

Two sprays in each nostril BID for up to 16 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 26575524 RESULT

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 21, 2024
• Results First Posted: December 19, 2013

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share