Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)

A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis

This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.

Inclusion Criteria:

• At least 18 years of age
• Bilateral nasal polyps
• Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)

Exclusion Criteria:

• Polypectomy within the last 6 months
• Unhealed nasal surgery/trauma
• >5 previous polypectomies
• Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
• Nasal infection
• Pulmonary tuberculosis
• Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
• Immunocompromised
• Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
• Known hereditary mucociliary dysfunction
• Significant nasal structure abnormalities
• Asthmatic attack within the past 30 days
• Asthmatic patients requiring >1000 mcg beclomethasone or equivalent
• Asthmatic patients not stable on corticosteroid therapy