Bronchiectasis With Acute Exacerbation

The Azithromycin to Modify Bronchiectasis Exacerbation Risk (AMBER) trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial in adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB). The trial evaluates whether azithromycin 250 mg orally once daily for 12 months, added to standard bronchiectasis care, reduces the occurrence of at least one bronchiectasis exacerbation during 12-month follow-up compared with matching placebo added to standard bronchiectasis care. Participants will be randomized in a 1:1 allocation ratio to standard care plus matching placebo or standard care plus azithromycin. The primary analysis will follow the intention-to-treat (ITT) principle. The AMBER trial is embedded within the Assiut University bronchiectasis translational research platform and is linked to the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework and the Bronchiectasis Phenotype Identification Model (BPIM). BASE and BPIM are not used for randomization stratification and will not modify the primary randomized comparison. The locked Version 1.0 methodological disclosure document, protocol, and statistical analysis plan (SAP), primary sample-size source code, and endpoint-level sample-size support matrix are archived in Zenodo: https://doi.org/10.5281/zenodo.20178963. The AMBER public preregistration is also available through the Open Science Framework (OSF) under Digital Object Identifier (DOI) 10.17605/OSF.IO/RE54V.

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic airway disease characterized by permanent bronchial dilatation, impaired mucus clearance, recurrent infection, airway inflammation, and repeated exacerbations. Existing bronchiectasis severity tools are clinically useful, but many depend on prior exacerbation history, hospitalization history, subjective symptom assessment, or culture-based microbiological classification. This prospective observational cohort study aims to develop and validate the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework. BASE is designed to classify current bronchiectasis severity and predict 12-month exacerbation risk using objective baseline functional, radiological, oxygenation, and inflammatory variables. Detailed methodological specifications, including variable definitions, scoring architecture, endpoint hierarchy, development-validation governance, and analytical integrity rules, are archived in a restricted-access Zenodo record: https://doi.org/10.5281/zenodo.20143505 . Participants will receive routine clinical care, and no treatment or intervention will be assigned by the study protocol. Patients will be followed for 12 months to record bronchiectasis exacerbations, hospitalization, lung-function change, inflammatory marker change, and clinical outcomes. The Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework includes two linked baseline models: the BASE Severity model (BASE-S) for current bronchiectasis severity classification and the BASE Prognostic model (BASE-P) for prediction of 12-month exacerbation risk. Both models will be derived in the development cohort and applied unchanged to the validation cohort.

The Bronchiectasis Phenotype Identification Model (BPIM) is a prospective observational development-validation study within the Assiut University bronchiectasis translational research platform. The study evaluates whether latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes can be translated into a supervised baseline classifier for adults with non-cystic fibrosis bronchiectasis (NCFB). Latent class trajectory analysis (LCTA) will first identify trajectory-derived phenotype classes using prospectively collected longitudinal disease-signature data. The Bronchiectasis Phenotype Identification Model (BPIM) will then be trained to predict the accepted latent class trajectory analysis (LCTA)-derived phenotype class using the locked baseline disease-signature architecture. This study is observational and non-interventional. No treatment, medication, intervention, exposure, or management strategy is assigned by the protocol. All participants receive routine clinical care according to institutional practice and treating physician judgment. The locked methodological disclosure, protocol, and deterministic statistical analysis plan are archived in the version-specific Zenodo record: https://doi.org/10.5281/zenodo.20157926.

Acute exacerbations of bronchiectasis are associated with variable outcomes depending on patient factors. Comorbidities such as COPD, diabetes, and cardiovascular disease, as well as disease severity scores, significantly influence hospitalization rates, length of stay, need for intensive care, and mortality. Understanding these associations helps in risk stratification, guiding management, and improving prognosis in affected patients.

Randomized single-center trial evaluating whether bronchoscopic instillation of levofloxacin or gentamicin improves outcomes compared to a sham bronchoscopic procedure in adult ICU patients with non-cystic fibrosis bronchiectasis requiring invasive mechanical ventilation. The primary outcome is a ranked composite of in-hospital mortality and time to ventilator liberation. Safety and procedural adverse events are closely monitored.

Many people with chronic lung disease have disease flare-ups. It was previously believed that these were mainly caused by bacteria but recent evidence suggests that viruses could be an important trigger. This study will recruit volunteers with chronic lung disease and take samples both when well (at baseline) and during flare-ups (exacerbations) to better understand the role of viruses in triggering exacerbations and also how the immune response is affected. The researchers will follow the volunteers\' progress for up to two years. Whenever they get unwell they will take some samples (nose swabs, finger prick testing, phlegm sample) and post them to the researchers. Then, they will come in for a visit for more samples (blood tests, further swabs) and a review.

The goal of this study is to determine if viral infection with the common cold leads to an exacerbation in participants with bronchiectasis. The investigators will compare the participants with bronchiectasis to a group of healthy participants. The main questions it aims to answer are: * Does viral infection with the common cold lead to an exacerbation in bronchiectasis? * Does the immune response differ to that of a healthy participant? Participants will attend for a screening visit to see if they are eligible. All participants who are eligible and have consented to take part will have baseline investigations done including blood tests and a bronchoscopy. They will be given a spray of a virus that causes the common cold into their nose. They will then be followed up over the next 6 weeks with some of the following procedures at each study visit; spirometry, nasosorption, nasal lavage, nasal brushing, blood test, sputum collection and a bronchoscopy. Participants will be asked to keep a daily record of their symptoms throughout the study.

Title: Comparison of Effectiveness Between Active Cycle of Breathing Techniques (ACBT) and Oscillating Positive Expiratory Pressure (OPEP, Aerobika) Device Assisted Treatment in Patients With Bronchiectasis in Korea: A Randomized Controlled Trial Purpose: This study aims to evaluate the effectiveness of Active Cycle of Breathing Techniques (ACBT) alone versus ACBT combined with an Oscillating Positive Expiratory Pressure (OPEP) device (Aerobika) in patients with bronchiectasis. The goal is to determine whether the combination therapy reduces the frequency of acute exacerbations and improves patient symptoms compared to ACBT alone. Primary Questions: Does the use of ACBT plus Aerobika reduce the number of acute exacerbations in patients with bronchiectasis who experience ≥3 exacerbations per year? What symptoms and adverse events are observed in participants using the Aerobika device? Study Design: This is a single-center, randomized, controlled clinical trial conducted at Chungbuk National University Hospital in Korea. 100 adult patients diagnosed with bronchiectasis and having ≥3 acute exacerbations within 1 year will be enrolled and randomized into two groups (1:1): Active Cycle of Breathing Technique (ACBT) group Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group The intervention period lasts 12 months, with clinic visits scheduled at 0, 1, 3, 6, 9, and 12 months. Participation Involves: Use of ACBT with or without Aerobika daily for 12 months In-person clinic visits every 1 to 3 months Monthly phone follow-ups to assess symptoms and adverse events Completion of questionnaires (mMRC, BHQ, CAT) and clinical tests including PFT and laboratory tests Tracking of exacerbation frequency, sputum volume, and quality

Bronchiectasis is a clinical syndrome characterised by chronic cough, profuse sputum and/or intermittent haemoptysis, with or without shortness of breath and respiratory failure of varying severity, and abnormal thickening and dilatation of the bronchial walls as seen on lung imaging. Nebulised inhalation of N-acetylcysteine has been shown to significantly improve symptoms, shorten the length of hospital stay, reduce the rate of re-hospitalisation within six months, and improve lung function in patients with bronchiectasis with a high degree of safety. There have been no studies on the efficacy and safety of bronchoscopic irrigation with N-acetylcysteine solution in the treatment of bronchiectasis. The aim of this study was to investigate whether bronchoscopic acetylcysteine lavage combined with conventional treatment is more beneficial to patients with bronchiectasis than conventional treatment combined with conventional bronchoalveolar lavage and conventional treatment without bronchoscopy, respectively.