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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Mometasone Furoate

Criteria

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