Clinical Research Directory

Respiratory Physiotherapy for Patients With Bronchiectasis

Study design: observational, retrospective Population: 270 patients diagnosed with bronchiectasis (BX) treated at the Respiratory Physiotherapy Unit of the Rehabilitation Service of the A Coruña and Cee Health Area. Objective: To determine the profile of patients diagnosed with BX (not due to cystic fibrosis) treated at the Respiratory Physiotherapy Unit of the Rehabilitation Service of the A Coruña and Cee Health Area between 1 January 2022 and 1 March 2026. Hypotheses: * Main hypothesis These patients exhibit a high degree of heterogeneity. It is expected that the characterisation of these patients' clinical and functional variables-such as lung function, respiratory muscle strength, frequency of exacerbations and chronic bronchial colonisation by microorganisms-will enable the identification of distinct patterns within this population. * Secondary hypotheses * Patients with a higher burden of comorbidity have a poorer clinical prognosis and make greater use of resources. * Respiratory rehabilitation interventions will lead to improvements in these variables. * The combined analysis of clinical, functional and microbiological variables will enable the identification of patient profiles at higher risk. Applicability: The study will provide specific and up-to-date knowledge, enabling the optimisation of follow-up strategies and the adaptation of RF interventions to patients' actual needs, thereby improving the quality of care. The results will contribute to the formulation of new research questions. Ethical considerations: The information will be processed in a pseudonymised manner, ensuring the confidentiality and security of the data in accordance with the General Data Protection Regulation. Given the retrospective nature of the study and compliance with the established pseudonymisation requirements, an exemption from informed consent will be requested from the Ethics Committee, in accordance with Additional Provision 17 of Organic Law 3/2018, relating to the processing of health data for research purposes, justified by the minimal risk involved and the privacy controls in place for the information. Estimated duration: 9-10 months from the date of approval by the Ethics Committee, including data collection, statistical analysis and the dissemination of results. Budget: No external funding required. Conclusion: This project will provide detailed and rigorous clinical information on patients with bronchiectasis in real-world clinical practice.

REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study

This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.

Study on Doses of Inhaled ALX1 in Adults With Bronchiectasis

This study will evaluate the safety and effects of ALX1, an inhaled investigational treatment, in adults with bronchiectasis. Participants will receive either ALX1 or a placebo (a treatment with no active medicine) for 14 days. The study will compare different dose levels of ALX1 to help identify appropriate doses for future research based on safety, tolerability, and changes in predictive biomarkers.

Combined Effects of Resonant Breathing and Qigong Exercises in Bronchiectasis

Bronchiectasis is a chronic lung disease characterized by permanent dilation of the bronchi, leading to persistent cough, mucus overproduction, dyspnea and frequent respiratory infections. It is persistent respiratory symptoms and irreversible airway dilation due to chronic inflammation and impaired mucociliary clearance, often resulting from repeated infections or underlying conditions. This conditions leads to chronic cough, sputum production and breathlessness. Pilmonary rehabilitation is recommended as a reliable strategy for respiratory management, leading to improved lung function, reduced dyspnea and enhanced quality of life. Resonant breathing and Qigong exercise are effective in enhancing respiratory function by improving oxygen intake, relaxation and respiratory muscle strength. A randomized controlled trial will be conducted at DHQ Hospital Sheikhupura. Sample size is 46 calculated by epitool sample size calculator Convenient Sampling Technique will be used age 40 to 65 years consent will be obtained from all patients. Patients will be randomly assigned to group A and group B using simple random sampling. Group A will receive resonant breathing training with standard medical treatment. Group B will received combination of resonant breathing and Qigong exercises. Outcome measures include spirometer, MMRC dysnea scale and a quality of life questionnaire BHQ. Study will be completed within 10 months of duration treatment evaluation will be done after 3 weeks of exercise training program data will be processed using SPSS version 25. normality of data will be assessed through the Shapiro-Wilk test to determine the application of either

First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients

The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and participants with a bacterial infection (bronchiectasis participants chronically infected with P. aeruginosa).

Cardiopulmonary Responses to 6-Minute Stepper Test in Bronchiectasis Versus Healthy Controls

Individuals with bronchiectasis exhibit productive cough and recurrent lung infections as well as reduced exercise capacity, physical activity level, and respiratory and peripheral muscle strength. 6-minute walk test (6MWT) is often used to assess exercise capacity in chronic lung diseases. 6MWT is recommended to be performed along a flat corridor, at least 30 m long, with low pedestrian traffic, on a hard surface. To overcome technical limitations during 6MWT, 6-minute stepper test (6MST) has been proposed to assess exercise capacity. Another test that provides information about exercise capacity is the 1-minute sit-to-stand test (1STS). To our knowledge, there is limited information about different exercise tests including 6MST and 1STS and cardiopulmonary responses to these tests in individuals with bronchiectasis. Therefore, this study aims to compare the responses to the 6MST between individuals with bronchiectasis and healthy controls and to investigate the relationships among 6MST, 6MWT, and 1STS responses and muscle strength.

Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases

Pulmonary rehabilitation is a key treatment for lung diseases, but many patients struggle to attend sessions due to travel distances, physical limitations, or logistical barriers. The purpose of this study is to evaluate whether a tele-pulmonary rehabilitation (TPR) program can improve the rates of treatment initiation and adherence among patients with chronic lung diseases compared to traditional, center-based pulmonary rehabilitation. Additionally, the study will assess improvements in quality of life, physical symptoms, and safety in both groups. This study will enroll 90 patients from two medical centers in Israel (Tel Aviv and Barzilai). Participants will be randomly assigned to one of two groups: 1. The control group will receive usual care with a referral by a pulmonologist to standard pulmonary rehabilitation at a medical center. 2. The intervention group will participate in a supervised remote tele-rehabilitation program using a dedicated application and remote monitoring.

Role of BARriers in IgG-Pathogen Interactions at the Mucosal Surface in Human Airways

Context. Non cystic fibrosis bronchiectasis (NCFB) is a group of suppurative chronic airway diseases of multiple causes. Bronchiectasis is characterized by an abnormal, irreversible dilatation of the bronchi, airway obstruction, chronic cough, and sputum production. Inhaled polyclonal immunoglobulin G (IgG) is a new therapeutic approach for NCFB. Inhaled IgG is expected to have beneficial effects due to its ability to reduce the range of respiratory pathogens capable of infecting the respiratory tract, decrease the pulmonary load of existing bacterial populations, improve mucociliary clearance by restoring epithelial cell functions, and decrease lung inflammation. Pre-clinical data packages showed that IgG reduced the airway pathogen load and related cell damage after infection in rodents and non-human primates. The aim of this study is collect information on the impact of NFCB airway mucus on the biological barriers to locally delivered IgG. Study design. Thirty patients with stable NFCB will be recruited. The patients will provide induced sputum samples after inhaling isotonic saline. Induced sputum will be used for 1) identification of colonizing bacteriological, fungal and virological populations and 2) for in vitro pharmacological experiments. The main outcome is the quantification by whole-cell ELISA of binding to Pseudomonas aeruginosa by a polyclonal IgG in the presence of mucus derived from the sputum of NCFB patients. Secondary outcomes are (1) the measurement of proteolysis, by Western-Blot, of exogenous polyclonal IgG added in the mucus derived from sputum of NCFB patients. The results will be expressed as a percentage of integrity over the one obtained when the polyclonal IgG is added in saline solution and will be compared with in vitro results; (2) the measurement of mobility by Fluorescence Recovery After Photobleaching (FRAP) of exogenous fluorescently-labelled polyclonal IgG added in the mucus derived from sputum of NCFB patients. The results will include the determination of the t(1/2), mobile and immobile fractions over the one obtained when the polyclonal IgG is added in saline solution and will be compared with in vitro results; (3) impact of microbial airway colonization on IgG binding, proteolysis and Ig mobility. Samples with microbial colonization (either bacterial, viral or fungal) will be compared with uncolonized samples. This project will help in decision-making in the development of inhaled antibody therapeutics. Specifically, the study will provide information on the capacity of locally applied polyclonal IgG to diffuse through mucus and bind to pathogens.

Azithromycin to Modify Bronchiectasis Exacerbation Risk

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.

Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

People with bronchiectasis are prone to Pseudomonas aeruginosa (PA) infections, which can become chronic and lead to increased death rates and disease severity. Studies from cystic fibrosis suggest that eradication therapy aimed at PA can successfully transition patients to a culture-negative status, providing long-term benefits. Current guidelines for managing bronchiectasis in adults recommend eradicating PA when it is first or newly isolated; however, there is a lack of randomized controlled trials supporting such recommendations. The researchers hypothesize that both oral ciprofloxacin combined with tobramycin inhalation solution and tobramycin inhalation solution alone are superior to no eradication (inhaled saline) in terms of the eradication rate of PA (with eradication defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more after the first drug administration).

Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)

The purpose of this study is to collect data to assess the use of the LibAirty™ System for improving bronchiectasis symptoms and healthcare resource utilization when it is used at home. The main question this study is trying to answer is: How often do adults with bronchiectasis experience pulmonary exacerbations (flare-ups of their lung condition) while using the LibAirty™ airway clearance system at home? Participants will use the LibAirty™ airway clearance system at home as prescribed by their doctor - the device is not being provided as part of the study. The study will last for 12 months from the time participants begin using LibAirty. During the study period, participants will continue with their usual clinic visits. At some of these regular visits (up to 4 times over the year), participants will be asked to complete short questionnaires about their bronchiectasis symptoms and their experience using LibAirty. At these same visits, the study team will also review participants' medical records and collect information related to their bronchiectasis condition, such as test results, medications, and any hospital or emergency room visits.

Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis

Physiotherapy is a key treatment for patients with bronchiectasis. An evaluation of the parameters indicative of respiratory health in patients treated with two different respiratory physiotherapy techniques (conventional versus Simeox®) would be very useful in choosing physiotherapy treatments for bronchiectasis patients. A systematic review of the literature shows that there are no published studies evaluating the effectiveness of respiratory physiotherapy by analyzing the variation in resistance measured using the forced oscillation technique (FOT) in patients with bronchiectasis. The results of this study would add to those that have examined different physiotherapy techniques and could therefore contribute to the choice of the most appropriate technique for this category of patients. The trial is being conducted to answer the question: "How do respiratory parameters vary during treatment with two different respiratory physiotherapy techniques: conventional respiratory physiotherapy or that performed using the Simeox device?" Secondary objectives include the measurement of various functional parameters, such as vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure values) and spirometry values (FEV1, FVC, TLC). The onset of adverse events, the degree of patient tolerance and relief, and respiratory health will also be assessed through the administration of various questionnaires commonly used in clinical practice. Additionally, changes in the quantity of sputum produced will be measured.

Effects of Expiratory Muscle Training Added to Pulmonary Rehabilitation in Patients With Bronchiectasis

This randomized, single-blind, parallel-group controlled trial aims to investigate the effects of expiratory muscle training added to standard pulmonary rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, dyspnea perception, and quality of life in patients with non-cystic fibrosis bronchiectasis. Eligible patients aged 18-70 years with stable disease will be randomly assigned to either a pulmonary rehabilitation-only group or a pulmonary rehabilitation combined with expiratory muscle training group. Outcomes will be assessed at baseline and after completion of the intervention period.

Novel Sensors and Artificial Intelligence for Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis and Bronchiectasis

The goal of this observational study is to learn about new sensors that measure changes in the body that happen during a chest infection, such as breathing rate and heart rate. This study will be with adults who have either cystic fibrosis or bronchiectasis who start treatment with intravenous antibiotics (usually for around 2 weeks). The main question it aims to answer is the change in sensor measure (such as heart rate) between the start and end of treatment for a chest infection. No follow up visits are required for this study.

The C-BRIDGE Study: China Bronchiectasis Research Involving Databases, Genomics, and Endotyping

Bronchiectasis is a heterogeneous airway disease with diverse causes, making precise diagnosis, prognosis, and treatment response prediction challenging. Identifying patient subgroups (phenotypes) and molecular profiles (endotypes) can enhance individualized assessment and management. While prior studies, primarily in European populations, have identified key phenotypes and endotypes, their relevance to Chinese patients remains unclear due to geographic and clinical differences. Specific causes of bronchiectasis, such as allergic bronchopulmonary aspergillosis (ABPA) and primary ciliary dyskinesia (PCD), may also exhibit distinct pathophysiology requiring further exploration. The C-BRIDGE Study seeks to characterize phenotypes and endotypes in Chinese bronchiectasis patients during stable disease and exacerbations, evaluate differences in clinical outcomes across these subgroups, and develop personalized medicine strategies based on these findings, applicable in China and globally. Primary Objective: To identify molecular endotypes of bronchiectasis that accurately predict prognosis and guide treatment responses. Secondary Objectives: To characterize molecular endotypes of stable bronchiectasis in Chinese patients. To define molecular endotypes of bronchiectasis exacerbations in Chinese patients. To investigate molecular endotypes specific to allergic bronchopulmonary aspergillosis (ABPA). To explore genotypes and inflammatory endotypes of cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) in Chinese patients. To validate candidate biomarkers for stable and exacerbation endotypes to support stratified medicine. To conduct in vivo or in vitro proof-of-concept studies using phenotypic data to identify patient subgroups likely to benefit from specific pharmacological interventions. Study Design: This observational cohort study will link identified patient subgroups with meaningful clinical outcomes to inform prognosis and optimize treatment strategies.

Exploring How Viral Infections Affect People With Chronic Lung Disease

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.

A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis

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.

Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.

Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)

The ERASE II study is a prospective follow-up study designed to assess the long-term impact of successful eradication of Pseudomonas aeruginosa (PA) in patients with bronchiectasis. Building on the findings of the initial ERASE study, which evaluated the efficacy and safety of Tobramycin Inhalation Solution, ERASE II aims to determine whether successful PA eradication influences patient prognosis over an extended period. The study will involve a total observation period of 36 months, consisting of the initial 9 months of the ERASE study followed by an additional 27 months of comprehensive follow-up. Key outcomes to be assessed include patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall treatment costs. Additionally, the study will examine the timing and incidence of any potential reinfections with Pseudomonas aeruginosa.

Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis

The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.

Optimization of Nutritional State on the Outcome of Patients With Acute Exacerbation of Bronchiectasis

Bronchiectasis is a chronic respiratory condition characterized by the abnormal and permanent dilation of the bronchi, leading to recurrent respiratory infections, chronic cough, and significant morbidity. The disease has gained increasing recognition due to its rising prevalence and the substantial burden it places on healthcare systems . Recent studies have highlighted the importance of nutritional status in managing chronic respiratory diseases, including bronchiectasis. Malnutrition is prevalent among patients with bronchiectasis, particularly those experiencing frequent exacerbations. It has been shown that underweight patients have lower lung function and may face worse clinical outcomes compared to those with normal weight . Specifically, a study found that underweight individuals had a significantly lower forced expiratory volume in one second (FEV1) compared to their normal-weight counterparts, indicating a direct correlation between nutritional status and respiratory function .

Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis

Bronchiectasis is a chronic bronchial disease in which the usual capacity to remove secretions does not function correctly, causing mucus retention that leads to chronic infection. As with all infections, the use of antibiotics and puss removal are essential treatment elements. Physiotherapeutic techniques are used to assist in the removal of secretions, although these are time-consuming practices that need to be much better studied and which patients often do not continue practicing diligently. A physiotherapeutic technique called (Slow prolonged expiration in lateral decubitus) ELTGOL has been shown to be somewhat effective but as the mucus is viscous in this disorder, it can be difficult to get it to move. It is thought that saline solution inhalations may reduce mucus viscosity and could help to ease expectoration, facilitating the removal of the mucus by the physiotherapeutic technique. This project aims to test this hypothesis, which if true could represent an advance in the treatment of this severely debilitating disease.

Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.

The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping

Bronchiectasis is a complex heterogeneous disorder. Treatment is challenging and many recent randomized controlled trials have been negative. It is believed that bronchiectasis as a broad diagnosis incorporates multiple different patient subgroups (also known as phenotypes) and molecular entities (referred to as endotypes). This study aims to phenotype and endotype bronchiectasis during stable disease and exacerbations, to develop strategies for personalised medicine. Primary Objective To determine molecular endotypes of bronchiectasis which can guide response to treatment. Secondary Objectives 1. To determine molecular endotypes of stable bronchiectasis 2. To determine the causes and inflammatory profiles of bronchiectasis exacerbations 3. To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine 4. To perform in-vivo or in-vitro proof of concept studies using phenotypic data to identify patient populations likely to benefit in future randomized controlled trials This is an observational cohort study that will aim to identify patient subgroups and link these with meaningful clinical outcomes.