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

A double-blinded randomised control trial evaluating the efficacy of additional long-term low-dose Clarithromycin versus standard of care on post-operative symptomatic outcomes in the treatment of non-eosinophilic Chronic Rhinosinusitis in adults

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000688886

Enrollment

Registered

2021-06-07

Start date

2022-09-01

Completion date

2023-09-01

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to compare the addition of a low-dose antibiotic with properties that reduce inflammation to the therapy regimen after endoscopic surgery in chronic sinus disease, versus our current standard of care,

Interventions

The intervention will be a Long-Term Low-Dose Clarithromycin administration post endoscopic surgery. If participants meet all inclusion criteria, the intervention will commence 6 weeks post surgery. - the dose: 250mg once daily. - the duration of administration: 3 months. - the mode of administration: oral tablet.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results