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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01386125
First received: June 9, 2011
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Congestion/Obstruction Score [ Time Frame: Baseline and Weeks 1-4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 748
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01386125     History of Changes
Other Study ID Numbers: P05604
Study First Received: June 9, 2011
Results First Received: October 31, 2013
Last Updated: October 8, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Nose Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Mometasone furoate
Anti-Allergic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014