Preliminary Findings: The Feasibility Study for a Randomized Controlled Trial of Clarithromycin in Chronic Rhinosinusitis

Abstract

Objectives: There is currently conflicting level 1 evidence in the use of long-term antibiotics for chronic rhinosinusitis. The primary aim of this study was to look at recruitment and retention of patients in preparation for a formal trial. The aim of this paper is to describe the preliminary outcomes in terms of symptomatic relief in patients with CRSsNP. Methods: Adult patients fulfilling the EPOS criteria for CRSsNPs with no prior surgery were recruited in 6 UK centers during 2013. Participants received a 12-week course of clarithromycin 250 mg alongside topical mometasone and nasal douching, all twice daily. Follow-up was at 3 months and 6 months. For the purpose of this analysis, the Sinonasal Outcome Test (SNOT-22) score was recorded at baseline and both follow-up assessments. Results: Preliminary data from 29 patients at 3 months and 24 patients at 6 months showed significant symptomatic improvement in mean SNOT-22 scores on paired t tests at 3 months (40.4 to 33.7, P = .026), which was sustained at 6 months (30, P = .02). The number of subjects showing ≥9 point reduction in SNOT-22 scores was 45% (n = 13), increasing to 58% at 6 months (n = 14). Nine patients have been listed for surgery to date. Conclusions: While the results here do not have the power of the full randomized controlled trial, the findings suggest that long-term macrolides have the potential to achieve significant symptomatic reduction in approximately 50% of patients with CRSsNPs.