Evaluating the additional effect of clarithromycin in the standard of care for non-eosinophilic Chronic Rhinosinusitis patients

Phase 4

• Conditions: Chronic rhinosinusitis; Surgery - Other surgery; Inflammatory and Immune System - Other inflammatory or immune system disorders; Infection - Other infectious diseases

• Registration Number: ACTRN12621000688886
• Lead Sponsor: Professor Alkis Psaltis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants who meet ALL the following criteria will be offered inclusion in the study:

•Those who have had symptoms of chronic rhinosinusitis that has been previously persistent for greater than 3 months
•Are over 18 years of age
•Are English speaking
•Can give written informed consent
•Have underwent endoscopic sinus surgery prior
•Have a phenotype of non-eCRS on histological assessment
•Disease control has not been established 6 weeks post-op
•Can commit to return to the clinic for 12- and 18-weeks postoperative endoscopic examination.

Exclusion Criteria

Participants who meet one the following criteria will be excluded from the study:
•Allergy to macrolides
•language other than English spoken
•Pregnant or breastfeeding
•History of cardiac disease
•Allergy to steroids
•Covid-19 positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure will be the subjective symptom scores via the SNOT-21 questionnaire. <br>[The measurements are taken at 3 time points – 6 weeks, 12 weeks, and 18 weeks postoperatively. Timepoint 6 week and 18 weeks postoperatively are the primary timepoints.];primary outcome measure will be the subjective symptom scores via the visual analogue scale of discomfort. [These measurements are taken at 3 time points – 6 weeks, 12 weeks, and 18 weeks postoperatively. Timepoint 6 week and 18 weeks postoperatively are the primary timepoints.];primary outcome measures will be the endoscopy visual score via the Modified Lund Kenned Score. [ These measurements are taken at 3 time points – 6 weeks, 12 weeks, and 18 weeks postoperatively. Timepoint 6 week and 18 weeks postoperatively are the primary timepoints.]