The effect of chitosan-dextran (Chitodex) gel with budesonide and mupirocin on recalcitrant rhinosinusitis

Phase 1

Completed

• Conditions: Chronic Rhinosinusitis; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12616000329460
• Lead Sponsor: The Queen Elizabeth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be eradication of infection, indicated by a negative microbiology swab of the sinuses, clinical scores on endoscopy and symptom scores on patients’ self-directed questionnaires pre and post treatment.<br><br>The outcomes will be assessed by both the patient and an independent blinded clinician.<br><br>Pre and post treatment endoscopic scores will be performed by an independent blinded clinician using a scoring sheet specific for this study which consists of the validated Lund-Kennedy Endoscopic Score (LKES) with the addition of an evidence of infection section.<br><br>The patient will be scoring their pre and post symptoms using the VAS and SNOT-22 scoring sheet.[Sinus swab, endoscopy score and patient symptom scores will be assessed at baseline D0 of enrolment (pre-treatment) and at Day 7 +/- 2 days (post treatment).<br>]

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be patient comfort/discomfort following application of the gel compared to control (oral antibiotics) using a 5-point Likert Scale.[Post Treatment. Day 7 +/- 2 days.]