Comparing the effectiveness of steroid delivered via a nebuliser or a sinus rinse in the management of chronic rhinosinusitis.

Investigator initiated, single-centre, medical device, double blinded, randomised control trial to evaluate the safety, tolerability and effectiveness of topical Budesonide administered via a nebuliser at half the dose compared to Budesonide administered within a sterile saline intranasal wash in the management of chronic rhinosinusitis (CRS). A total of 54 participants will be enrolled in the study, which will allow for 27 participants in each treatment arm. Participants with symptomatic CRS who have had at least one prior sinus operation will be recruited from the Ears, Nose and Throat (ENT) Outpatient Clinic at The Queen Elizabeth Hospital. They will be randomly allocated to one of two treatment arms: either they will have daily nebulised steroid (0.5 mg Budesonide) and twice daily saline intranasal rinses for 6 weeks or, daily nebulised saline and twice daily saline rinses (one of which has 1 mg of Budesonide added) for 6 weeks. Patients will be given a 2 ml ampoule of colourless solution to add to their nebuliser solution and a 2 ml ampoule of colourless solution to add to one of their daily sinus rinses. Both of these ampoules will be over-labelled to disguise their contents (either Budesonide or sterile water depending on which arm they are recruited). Patient concurrent medication data, adverse events, symptom scores and endoscopic scores will be collected prior to initiation of trial and at the 6 week mark on completion of trial. We hypothesis that when administered via nebuliser P&S T45 TEKCELEO patented MICRONICE™ device, Budesonide will be able to be delivered to a larger surface area of sinonasal mucosa and hence be at least as, or more, effective at half the dose than when administered within an intranasal rinse. A nebulisation device will also allow patients an alternative option for self-administering topical Budesonide and decrease medication wastage.