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

Primary Purpose

Nasal Polyps

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone Furoate Nasal Spray (MFNS)
Placebo for MFNS
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mometasone Furoate Nasal Spray (MFNS)

    Placebo

    Arm Description

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

    Participants receive matching placebo nasal spray BID for 16 weeks

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2011
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01386125
    Brief Title
    A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasal Polyps

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    748 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mometasone Furoate Nasal Spray (MFNS)
    Arm Type
    Experimental
    Arm Description
    Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants receive matching placebo nasal spray BID for 16 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone Furoate Nasal Spray (MFNS)
    Intervention Description
    MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for MFNS
    Intervention Description
    Two sprays in each nostril BID for up to 16 weeks
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Congestion/Obstruction Score
    Description
    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.
    Time Frame
    Baseline and Weeks 1-4
    Title
    Change From Baseline in Total Polyp Size Score
    Description
    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.
    Time Frame
    Baseline and Week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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) 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    26575524
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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