A Study of the Effectiveness and Safety… | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo for MFNS

Drug

Two sprays in each nostril BID for up to 16 weeks

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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)

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jun 30, 2011
Registry last updated: May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed