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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386125
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : December 19, 2013
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Mometasone Furoate Nasal Spray (MFNS) Drug: Placebo for MFNS Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01386125     History of Changes
Other Study ID Numbers: P05604
First Posted: June 30, 2011    Key Record Dates
Results First Posted: December 19, 2013
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
Nasal Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents