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

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.

Timeline

Start

2003-09-01

Primary completion

2005-09-01

Completion

2005-09-01

Outcome

Met primary endpoint

paper median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; PMID 19289710 ↗

Publications

• Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302. doi: 10.1001/archoto.2009.2.

Drugs

Indications