Clinical trial NCT01386125: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Polyps
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-06-30
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Congestion/Obstruction Score
timeFrame: Baseline and Weeks 1-4
measure: Change From Baseline in Total Polyp Size Score
timeFrame: Baseline and Week 16
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.