None listed
Conditions
Brief summary
This research is aimed at improving outcomes for patients with chronic rhinosinusitis, particularly the cohort of patients who experience persistent CRS symptoms despite optimum medical and surgical therapy, termed as recalcitrant CRS (rCRS). We hope that we are able to developed an agent that could help manage persistent infections in patients with chronic rhinosinusitis even after they have had surgery and potentially improve patient's symptoms and reduce the need for revision surgery. The primary end point of this study is to: 1. To assess the efficacy of Chitodex-Budesonide-Mupirocin gel in treating patients with recalcitrant chronic rhinosinusitits Measured by: 1) Eradication of bacteria confirmed with microbiological swab 2) Independently scored video endoscopic examination of sinuses pre and post treatment 3) Patient's symptoms score pre and post treatment The secondary end point of this study is to: 1. Assess the tolerability of the treatment gel vs oral antibiotics
Interventions
Patients who meet ALL of the inclusion/exclusion criteria will be offered participation in this study and will be randomised into treatment and control group after informed consent has been obtained.
Under endoscopic guidance, test group patients will have a sinus swab performed, followed by 10mls of the Chitodex+budesonide+mupirocin (CBM) complex applied to each side of their sinuses (total 20mls of CBM gel in one patient) by the surgeon. This is experimental practice. The treatment gel consi
Patients who meet ALL of the inclusion/exclusion criteria will be offered participation in this study and will be randomised into treatment and control group after informed consent has been obtained. Under endoscopic guidance, test group patients will have a sinus swab performed, followed by 10mls of the Chitodex+budesonide+mupirocin (CBM) complex applied to each side of their sinuses (total 20mls of CBM gel in one patient) by the surgeon. This is experimental practice. The treatment gel consists of 10mL 5% chitodex + 2mL buffered saline + 2mg/4mL budesonide + 10mg/4mL mupirocin (total dose for bilateral sinus cavity). This will be applied under direct visual endoscopic guidance by the surgeon to ensure all sinus cavities are filled with gel and will add approximately an additional 15 minutes to the patient's usual appointment. Patients in the control group will be given culture sensitive oral antibiotics. This is usual practice. The patient will be asked to return to the outpatient department 7 days later for a repeat sinus swab and a recording of their endoscopic sinus examination. The endoscopic video examination will then be scored by a blinded independent clinician for infection (pus), oedema, granulation tissue, and crusting using a standardised scale which are the study outcomes of this study. In addition, patients will be asked to complete a self-directed symptom and comfort questionnaire at each time-point. If there are signs of persistent infection at 7 days post-application of the CBM complex, then a second swab will be taken and sent for repeat microbiological evaluation. Patients who were in the CBM group will receive another 10ml dose of CBM applied endoscopically by the surgeon into each side of their sinus cavity and patients who were in the control group will be swapped over to the gel group. If there are no further clinical signs of infection at the 1 or 2 week post-recruitment visit, the patient will have a final microbiology swab taken to confirm eradication of infection and would be considered as having completed the study. If the patient has still not improved after 14 days, they will resume usual outpatient/surgical care for their symptoms.
Sponsors
The Queen Elizabeth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selection/inclusion criteria: Patients who meet ALL of the following criteria will be offered inclusion in the study: (1) Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND (2) have had at least one operation for their chronic rhinosinusitis > 12 weeks prior to enrolment AND (3) continue to have ongoing symptoms despite surgical management AND (4) have not responded to at least one course of oral antibiotics (5) have a positive sinonasal swab that indicates infection of the sinuses AND (6) are over 18 years of age AND (7) are able to give written informed consent AND (8) are local patients who will be returning to this centre for postoperative follow-up care
Exclusion criteria
Exclusion criteria: (1) allergy to shellfish, steroids or mupirocin (2) pregnant or breastfeeding (3) immunodeficient patients (patients on any immunosuppressive or immunomodulatory agent) (4) on other CYP450 inhibiting drugs (e.g. ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (5) liver disease
Outcome results
None listed