Project overview
BACKGROUND: Bronchiectasis is a common lung condition affecting over 300,000 patients in the UK.
Up to 25% of these patients experience recurrent chest infections (or flare ups). A long-term antibiotic called azithromycin is used aiming to reduce the number of flare ups. Previous studies lasting 6-12 months suggest continuous use of azithromycin reduces flare ups by 20-30% but no longer term results are known.
Patients however commonly stay on azithromycin for years. We do not know if this prolonged use is of benefit to patients or if it risks antibiotic overuse and resistance without clear benefits. We polled over 100 patients attending specialist chest clinics/ online interest groups and over 75% expressed some concerns about being on long term antibiotics permanently.
AIM: The BOAT trial aims to discover if we can stop long-term azithromycin. The study will help clinicians and patients know if it is better to stop azithromycin or continue it.
METHODS: We will offer 1000 patients with bronchiectasis who are already taking long term azithromycin entry into a study lasting up to 2 years. We will recruit from 50-60 sites spread across the UK, with support from GPs/ community. Through a computerised random choice patients will get either azithromycin or a placebo (matched dummy) tablets. We will ask the patient to attend the trials centre four to five times over 2 years with phone calls if needed/ preferred by the patient. We will measure the "Time to the First Exacerbation/ flare up" after study entry and compare the two groups. Flare ups will be recorded by patients using a weekly paper diary and noted when an emergency antibiotic rescue pack is needed.
Patients could be in the study for 24 months on study provided azithromycin or dummy tablets. We will measure the total number of flare ups in the 12-month period and the number of hospital admissions and where possible, breathing tests.
We will find out how people feel using questionnaires (quality of life) and how cost effective the different approaches are.
Up to 25% of these patients experience recurrent chest infections (or flare ups). A long-term antibiotic called azithromycin is used aiming to reduce the number of flare ups. Previous studies lasting 6-12 months suggest continuous use of azithromycin reduces flare ups by 20-30% but no longer term results are known.
Patients however commonly stay on azithromycin for years. We do not know if this prolonged use is of benefit to patients or if it risks antibiotic overuse and resistance without clear benefits. We polled over 100 patients attending specialist chest clinics/ online interest groups and over 75% expressed some concerns about being on long term antibiotics permanently.
AIM: The BOAT trial aims to discover if we can stop long-term azithromycin. The study will help clinicians and patients know if it is better to stop azithromycin or continue it.
METHODS: We will offer 1000 patients with bronchiectasis who are already taking long term azithromycin entry into a study lasting up to 2 years. We will recruit from 50-60 sites spread across the UK, with support from GPs/ community. Through a computerised random choice patients will get either azithromycin or a placebo (matched dummy) tablets. We will ask the patient to attend the trials centre four to five times over 2 years with phone calls if needed/ preferred by the patient. We will measure the "Time to the First Exacerbation/ flare up" after study entry and compare the two groups. Flare ups will be recorded by patients using a weekly paper diary and noted when an emergency antibiotic rescue pack is needed.
Patients could be in the study for 24 months on study provided azithromycin or dummy tablets. We will measure the total number of flare ups in the 12-month period and the number of hospital admissions and where possible, breathing tests.
We will find out how people feel using questionnaires (quality of life) and how cost effective the different approaches are.
