Fluticasone propionate aqueous nasal spray does not influence the recurrence rate of chronic rhinosinusitis and nasal polyps 1 year after functional endoscopic sinus surgery
Article first published online: 3 SEP 2004
Clinical & Experimental Allergy
Volume 34, Issue 9, pages 1395–1400, September 2004
How to Cite
Dijkstra, M. D., Ebbens, F. A., Poublon, R. M. L. and Fokkens, W. J. (2004), Fluticasone propionate aqueous nasal spray does not influence the recurrence rate of chronic rhinosinusitis and nasal polyps 1 year after functional endoscopic sinus surgery. Clinical & Experimental Allergy, 34: 1395–1400. doi: 10.1111/j.1365-2222.2004.02044.x
- Issue published online: 3 SEP 2004
- Article first published online: 3 SEP 2004
- Submitted 3 October 2003; revised 28 November 2003; accepted 17 May 2004
- nasal mucosa;
- nasal polyps;
- paranasal sinus diseases;
- sinus surgery
Background Local corticosteroids are widely used in the treatment of nasal polyps and chronic rhinosinusitis both before and after nasal surgery. Their efficacy after functional endoscopic sinus surgery (FESS) has not been fully established by placebo-controlled trials.
Objective This double-blind placebo-controlled randomized study was performed in order to investigate whether fluticasone propionate aqueous nasal spray (FPANS) reduces the recurrence rate of nasal polyps and chronic rhinosinusitis during the first year after FESS.
Patients and methods The trial looked at 162 patients aged 18 years and older requiring FESS for chronic rhinosinusitis or nasal polyps. After FESS combined with peri-operative systemic corticosteroids, patients were randomized and given FPANS 400 μg b.i.d., FPANS 800 μg b.i.d. or placebo b.i.d. for the duration of 1 year. Patients were withdrawn from the trial (but still included in the study for statistical purposes) if there were recurrent or persistent diseases, defined as progressive regrowth of nasal polyps, recurrent signs and symptoms of chronic sinusitis combined with abnormalities on computed tomography scan and persistent complaints for at least 2 months after FESS.
Results A significant reduction of symptoms was seen after FESS. After 1 year, 46 patients had been withdrawn from the trial because of recurrent diseases and 32 patients because of persistent symptoms. No differences in the number of patients withdrawn because of recurrent or persistent diseases were found between the patients treated with FPANS and patients treated with placebo. We were also unable to find a positive effect of FPANS compared with placebo in several subgroups such as patients with nasal polyps, high score at FESS or no previous sinus surgery.
Conclusion This placebo-controlled study does not show that treatment with FPANS up to 1 year after FESS had a positive effect compared with placebo.