BOAT

Bronchiectasis: Optimising Azithromycin prevention Treatment 

Research summary

Bronchiectasis: Optimising Azithromycin prevention Treatment to reduce exacerbations (BOAT): A double-blind pragmatic 2 arm phase IV randomised controlled trial

People living with bronchiectasis may experience worsening symptoms such as shortness of breath, cough and wheezing in addition to changes that may be expected for having debilitating and frightening, requiring additional treatment, often with azithromycin. This is an antibiotic medicine that also has anti-inflammatory properties. It is prescribed as long-term prevention to reduce the risk of flare-ups. Some people may be affected by side effects from azithromycin. Antibiotic resistance is another concern, especially when using azithromycin for prevention rather than to treat active infection. It is currently unknown whether to advise people to stop taking azithromycin once bronchiectasis has stabilised. It is also unknown if azithromycin is more effective in some people or more likely to cause side effects in others.

Given these uncertainties, it is challenging to know how best to use azithromycin in managing bronchiectasis. Azithromycin is a valuable antibiotic. To Maintain its benefit while avoiding unnecessary side effects it is necessary to reduce the chances of bacteria becoming resistant to it. This trial aims to establish the effects of stopping azithromycin in people whose bronchiectasis has stabilized after taking it for at least 3 months. It will compare continuing azithromycin with stopping it completely, examining the effects of these two treatments on flare-ups, symptoms, and quality of life, and identifying factors that may affect individual responses.

Main inclusion criteria

To be included in the trial the participant must:

  • Be age 16 years or older (no upper age limit)
  • Be bale and willing to provide written informed consent
  • Have clinically stable Bronchiectasis, i.e. no Bronchiectasis exacerbation for at least 30 days. Established clinical diagnosis of Bronchiectasis and prescribed prophylactic azithromycin or an equivalent long-term macrolide for at least 90 days in the past 12 months to reduce risk of Bronchiectasis exacerbation
  • Historical CT scan report confirming bronchiectasis (or equivalent e.g. bronchogram)
  • Any suspected aetiology of Bronchiectasis can be included.
  • Any treatment regimen of Azithromycin or an equivalent long-term macrolide (noting current guidelines allow 250mg OD thrice weekly, 250mg each day or 500mg OD thrice weekly of azithromycin)

Available data (more than 5 parameters from the following routinely collected data) to calculate Bronchiectasis Severity Index (BSI) 1) age, 2) sex, 3) FEV1% predicted current or historical in last 12 months, 4) number of prior exacerbations, 5) prior hospitalisations in last 24 months, 6) MRC dyspnoea score, 7) microbiology status (Pseudomonas colonies or other), 8) BMI. CT Reiff scoring also preferred but not essential.

Main exclusion criteria

The presence of any of the following will preclude participant inclusion:

  • Known hypersensitivity to any of the trial drugs or excipients
  • Current breast feeding, pregnancy or planned pregnancy during the trial
  • Any medical history or clinically relevant abnormality that makes patient ineligible for inclusion because of a safety concern relating to continuing or discounting azithromycin or other considerations.
  • Bronchiectasis exacerbation requiring treatment with antibiotics and/or steroids up to 30 days prior to study enrolment (can be re-screened after 30 days)
  • Azithromycin prophylaxis prescribed for non-Bronchiectasis condition or as part of treatment regimen for NTM
  • Participation in other trial of investigational medicinal product of bronchiectasis (unless a co-enrolment agreement has been developed and approved). Participation in observational studies is allowed.
  •  Where participant/supervising clinician does not feel at equipoise for randomisation to either continuation or withdrawal of macrolide.
  • Participant has usual regimen of azithromycin of winter on therapy/summer cessation of therapy AND patient unwilling to be randomised to trial allocation for 12 months.

Funders and sponsors

Chief investigator

Chief Investigator: Prof Anthony De Soyza

Contact details

Clinical Trials Coordinator: Heike Templin/Guneswary Thaygaraja

Trial Email: cuh.boat@ nhs.net