Analysis of the Bat Randomised Controlled Trial: Effects of Maintenance Azithromycin on Bronchiectasis Patients' Radiological Features

Macrolide antibiotics have been demonstrated to be helpful in treating diffuse panbronchiolitis and cystic fibrosis (CF), and prior research has also suggested that they may be helpful in treating non-CF bronchiectasis. For people with non-CF bronchiectasis, to evaluate the effectiveness of macrolide maintenance therapy. The randomised, double-blind, placebo-controlled BAT study (Bronchiectasis and Long-term Azithromycin Treatment). Number of infectious flare-ups throughout treatment months. Lung function, sputum bacteriology, inflammatory markers, negative effects, symptom ratings, and quality of life were considered secondary end goals. A decreased rate of infectious exacerbations occurred among people with non-CF bronchiectasis when azithromycin was taken every day for many months as opposed to a placebo. Better survival odds and a higher quality of life might follow from this, albeit the impact on antibiotic resistance has to be taken into account.
The BAT (Bronchiectasis and Long-term Azithromycin Treatment) experiment was a parallel-group, double-blind, placebo-controlled study with equal randomization that was conducted across many centres. All study sites' ethical review committees reviewed and approved the study protocol, and the study was carried out in accordance with the Declaration of Helsinki's most recent revision, the International Conference on Harmonization's guidelines for good clinical practise, and the Good Clinical Practice guidelines. The research followed the recommendations of CONSORT (Consolidated Standards for the Reporting of Randomized Controlled Trials).
At each of the research locations, the investigator or the pulmonary doctor recruited patients from the outpatient clinics. Patients were randomised after their medical histories had been evaluated and they had given written informed permission. The number of infectious exacerbations over the seven-week therapy period was the main result. An rise in respiratory symptoms necessitating antibiotic therapy was referred to as an infectious exacerbation. We chose to exclude the few occurrences not treated with antibiotics from the analysis of our primary end goal even though the original protocol called for the inclusion of events treated with steroids and antibiotics.
Every treating doctor (including lung doctors and general practitioners) was advised to contact the researchers by phone or fax to report any exacerbations. Patients were particularly questioned about exacerbations during the previous months at each follow-up appointment. A member of the research team paid each participant a visit at their individual hospitals at the conclusion of the study. The researcher double-checked the patient's medical records during these visits to see if there were any mentions of infectious exacerbations, antibiotic courses, or both. All patients were examined by the researcher at the initial study appointment, and they each received a subject identification code with a double-blinded allocation to either azithromycin or a placebo. Placebo pills were created by a trial pharmacy with a licence and were identical to azithromycin in terms of look, texture, and taste.
Data from the modified intention-to-treat population, or all randomised individuals who received at least one dosage of the trial medication, were analysed statistically. Patients who were randomly assigned but afterwards seemed to not meet the inclusion criteria were not given study medication and were eliminated from the analysis. A t test was used to compare parameters across treatment groups if they were normally distributed, and a Mann-Whitney U test was used if they weren't. During the intervention, there were no patients who lacked information on exacerbations.
A recent study on non-CF bronchiectasis (the EMBRACE trial) discovered that months of macrolide therapy significantly decreased the frequency of exacerbations. Better QOL and improved lung function were not sustained six months after the intervention ended. Unlike the EMBRACE trial, which discovered a modest but substantial decline in the already low baseline CRP readings, our study's CRP values did not significantly alter, most likely due to insufficient power for this secondary end point.
To our knowledge, this study is the first to assess the effectiveness of azithromycin maintenance therapy throughout the course of a full year, therefore minimising the impact of seasonal variations on the frequency of exacerbations and general wellbeing. The majority of the sputum pathogens were examined for macrolide resistance; this adds crucial details to past studies in the area, especially since the development of resistant organisms was not accompanied by a decline in efficacy in the following months.
This randomised controlled experiment proved the favourable impact of long-term AZM therapy on radiological characteristics. The effectiveness of therapy for bronchiectasis may be evaluated objectively using high resolution computed tomography.