Phase 3 N=748 Randomized Double-blind Treatment

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

Nasal Polyps

Bottom Line

View on ClinicalTrials.gov: NCT01386125 ↗

Enrolled (actual)

748

Serious AEs

0.7%

Results posted

Dec 2013

Primary outcome: Primary: Change From Baseline in Congestion/Obstruction Score — -0.56; -0.42 score on a scale — p=0.0007

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mometasone Furoate Nasal Spray (MFNS) (Drug); Placebo for MFNS (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Congestion/Obstruction Score	-0.56; -0.42	0.0007 sig
PRIMARY Change From Baseline in Total Polyp Size Score	-0.76; -0.45	<0.0001 sig

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01386125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.