Projects per year
Methods: A 3-arm parallel group trial will be conducted where patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care) will be randomised to receive either intranasal medication plus endoscopic sinus surgery, intranasal medication plus clarithromycin (250mg) or intranasal medication plus placebo. Intranasal medication (current standard medical care) is defined as intranasal corticosteroids (INCS) spray or drops and saline irrigations. The primary outcome measure is the disease-specific health related quality of life SNOT-22 questionnaire. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted through at least 16 secondary/tertiary care centres with an internal pilot at 6 sites for 6 months.
Discussion: The potential cardiovascular side-effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through the trial, reducing unnecessary usage and potential morbidity. With respect to ESS, if it is shown to be clinically and cost effective, the trial may encourage earlier intervention. In contrast, if shown to be ineffective, this should achieve significant reductions in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with Chronic Rhinosinusitis (CRS) and design the ideal patient pathway across primary and secondary care.
Trial registration: ISRCTN no: 36962030 (17th October 2018)
- chronic rhinosinusitis
- endoscopic sinus surgery
- randomised controlled trial
- 1 Active
- 13 Citations (Scopus)
- 1 Article
Antibiotic usage in chronic rhinosinusitis: analysis of national primary care electronic health recordsHopkins, C., Williamson, E., Morris, S., Clarke, C. S., Thomas, M., Evans, H., Little, P., Lund, V. J., Blackshaw, H., Schilder, A., Philpott, C., Carpenter, J. & Denaxas, S., Dec 2019, In: Rhinology. 57, 6, p. 420-429 10 p.
Research output: Contribution to journal › Article › peer-reviewOpen AccessFile14 Citations (Scopus)15 Downloads (Pure)