A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
Condition: Nasal Polyps
MeSH terms: Nasal Polyps; Polyps
Intervention: Mometasone Furoate Nasal Spray (MFNS); Placebo for MFNS
Intervention description: MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks; Two sprays in each nostril BID for up to 16 weeks
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 748.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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