Clinical Research Directory

Natural History of Bronchiectasis

Background: * Bronchiectasis is a disease characterized by airways that are inflamed, abnormally dilated, and chronically infected. Individuals with bronchiectasis have a history of chronic and recurring respiratory infections. Depending on the underlying cause, these infections may involve the entire respiratory tract, resulting in sinus, ear, and lung disease. * Bronchiectasis continues to be a significant problem in developing countries and in specific groups of individuals, particularly in people who have cystic fibrosis. Although treatments are available or under development for bronchiectasis related to cystic fibrosis, many of the disease-specific treatments may not be effective for bronchiectasis not related to cystic fibrosis. Objectives: \- To study the natural history of bronchiectasis to identify inherited and immune factors that may explain why certain individuals have chronic recurring infections. Eligibility: * Individuals 5 years of age and older who have an established diagnosis of bronchiectasis or a history of chronic/recurring respiratory infections. * Direct family members (e.g., parents, siblings, children) of patients in the study may also be asked to participate. Design: * Potential participants will be screened with an initial clinic evaluation and full medical history, as well as a general quality of life and respiratory symptom questionnaire. * The following standard procedures may be done as part of the study: air sampling from the nose; imaging studies, which may include an x-ray or computed tomography (CT), lung function tests; and collection of samples of blood, urine, and sputum (phlegm or mucus). Other tests may be performed as required by the researchers, and will be explained to patients as needed. * Both patients and relatives (if asked to participate) will provide the following samples: blood or buccal (cheek swab) cells for genetic testing, sputum, and urine. * To prevent infections and potential disease progression, patients may receive standard medical care and treatment for bronchiectasis and related infections during this protocol.

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis

This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease. The study will also test how the body processes the drug and to check for any immune reactions. Participants will be divided into groups randomly to receive either one of two different doses of the study drug or a placebo. The main goal of the study is to see how well the drug works compared to the placebo in helping those with bronchiectasis.

Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine

This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose. Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.

Cardiovascular Comorbidities and Bronchiectasis

Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Natural history is marked by recurrent infectious diseases which are the main prognosis factor. This disease is associated with an inflammation rate in the lung as well as in the blood. Up to now, no study has been described comorbidities associated with this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent in these patients. In fact systemic inflammation driven by bronchial infections may increase frequency of cardiovascular diseases. The investigators decide to conduct a monocentric observational study to define the prevalence and characterization of cardiovascular comorbidities as well as markers of accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are frequent in bronchiectasis and may be associated with markers of inflammation and aging. Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed. Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations. Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed. Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.

A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.

THERMotherapy Against Persistent Bacterial LUNG Infections

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease

This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline for 6 months or delayed initiation consisting of normal saline inhalation during the first 3 months followed by 3% hypertonic saline during the subsequent 3 months. The primary objective is to compare respiratory symptom improvement between hypertonic saline and normal saline at Month 3. Secondary objectives include evaluating sputum microbiological outcomes, radiographic changes, inflammatory markers, small airway function, treatment initiation, safety, and within-participant changes before and after switching from normal saline to hypertonic saline in the delayed-initiation arm. The first participant was enrolled on October 3, 2025.

Breathlessness Perceptions Within Respiratory Diseases

Breathlessness is a complex symptom that results in poor quality of life, increased hospitalisations and increased mortality. Breathlessness is influenced by physiological, psychological and functional factors but these are poorly explored. There are also unexplored phenomenon's such as breathing pattern. Therefore, this study aims to understand the influences of physiology, psychology, function and breathing pattern on health related quality of life in those with a respiratory disease compared to healthy controls. This project is a cross-sectional cohort study including those with a known respiratory disease and experiencing breathlessness, compared to non-breathless healthy controls. The investigators will measure your physiology through spirometry (a breathing test that tells us about their lung function), psychology through questionnaires, function through an exercise test and breathing pattern using opto-electrictronic plethysmography (markers are placed on your chest to see how participants breathe while exercising). This will be conducted over two visits. The investigators will recruit participants from clinics at the University Hospitals of Leicester NHS Trust. The investigators are aiming to recruit 50 participants with a respiratory disease and 25 healthy controls. The results of this study will help us understand breathlessness in more detail in order to be able to develop better treatments.

A Study to Evaluate the Diagnostic Performance of Portable Oscillometry Across Chronic Respiratory Diseases

This is a prospective, multicenter, observational cohort study enrolling approximately 4,000 subjects across about 50 centers, including patients with COPD (confirmed and suspected), asthma (confirmed and suspected), bronchiectasis, interstitial lung disease (ILD), upper airway obstruction (UAO), and healthy controls. Participants will undergo standardized clinical assessments, cough search, FENO, ETCO2, impulse oscillometry, spirometry, and/or bronchodilator test, and/or bronchoprovocation test, and/or diffusion capacity test at a single baseline visit, with no investigational intervention or treatment assignment. The primary objective is to evaluate the diagnostic performance of portable impulse oscillometry in Chronic respiratory diseases and to develop an artificial intelligence diagnostic model for COPD based on oscillometry. The study duration per subject is limited to the screening/baseline visit, with no follow-up visits planned.

Itraconazole Therapy In Bronchiectasis With Airway Mold

The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and airway mold. Feasibility will be assessed through recruitment success, treatment adherence, tolerability, and participant retention. The study will also explore the impact on respiratory symptoms and airway microbiome diversity.

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.

Bronchiectasis Phenotype Identification Model

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.

Health Impact of Non-Tuberculous Mycobacteria Pulmonary Disease (NTM-PD)

Nontuberculous mycobacteria (NTM) are environmental organisms found in soil and water. The majority do not cause human disease. When they do, this is mostly as a chronic lung infection in people with long-term lung problems such as chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis. The number of people with NTM pulmonary disease (PD) is increasing, and its management can be complex, requiring prolonged treatment with multiple, often toxic, drugs in someone who may already be frail. Non-drug approaches, such as airway clearance techniques, structured exercise, nutritional support and psychological care are used to help manage bronchiectasis and COPD. However, there is limited evidence about their benefit in people with NTM-PD. Also, it is not clear whether these patients' health needs are different from people with bronchiectasis alone. The investigators want to identify the most important symptoms encountered by people with NTM-PD and patient preferences for care. The study also aims to explore whether the need for non-drug measures differs between people with and without NTM-PD who have other underlying lung disease. The research will take place at one NHS centre and involve a single assessment of 40 people with NTM-PD not using specific antibiotics to treat their NTM and 40 people with bronchiectasis but no evidence for NTM. Following consent, and mainly using questionnaires, participants will be asked about their physical and mental health, and nutritional status. Exercise capacity, muscle strength and body muscle/fat composition will also be assessed using simple tests. The total time required will be a maximum of one hour. Recruitment to the study will last around six months. The results will help improve understanding of specific needs of people with NTM-PD and guide clinically relevant research in this area.

Study of Bronchiectasis and Associated Cardiovascular Comorbidities

Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis

HFNC in Management of Bronchiectasis Exacerbation

Patients with Bronchiectasis experience exacerbations with hypercapnic respiratory failure associated with an increased respiratory workload that may require intensive care unit (ICU) admission due to the inability of the respiratory muscles to compensate for increased demand. These exacerbations are frequently treated with noninvasive ventilation (NIV).

Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases

This upcoming case-control study aims to confirm the Lung Sliding Index (LSI), a new ultrasound score that measures how well the pleura moves, in various lung diseases. The study will check how well the LSI can tell apart different lung diseases (like pneumothorax, interstitial lung disease, COPD, pneumonia, and pulmonary edema), how it relates to signs of disease severity, and how consistent the results are between different operators who have received the same training. Secondary objectives include assessing patient and operator satisfaction and feasibility using validated Likert scales.

Telerehabilitation in Patients With Bronchiectasis

Background: Home-based telerehabilitation (TR) has demonstrated benefits comparable to conventional rehabilitation in patients with chronic obstructive pulmonary disease, asthma, and pulmonary fibrosis. However, TR has not been thoroughly investigated in patients with bronchiectasis, despite evidence suggesting improvements in exercise capacity and quality of life. Aims: To evaluate the effects of TR on functional capacity, quality of life, and inflammatory biomarkers, as well as its safety in patients with bronchiectasis. Study design: Single-center randomized controlled trial with a parallel-group design. Methods: Patients diagnosed with bronchiectasis will be recruited from the Surgical Medical Unit for Respiratory Diseases at Virgen del Rocío University Hospital. Participants will be randomly assigned to one of two groups: a control group receiving usual care, and a TR group undergoing supervised physical training for 12 weeks, three times per week. Outcome measures will include the 6-minute walk test, quality-of-life questionnaires, pulmonary function tests, symptom assessment, and adverse event recording, as well as sputum microbiology and analysis of inflammatory biomarkers. Assessments will be conducted at baseline and at the end of the intervention. Expected results: A 12-week TR program is expected to significantly improve exercise capacity and quality of life in the intervention group. Additionally, this study may contribute to the development of future clinical guidelines regarding the use of TR in patients with bronchiectasis.

OLE Therapy With BE Patients in Home Care Study

The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE). The patient will use the BiWaze Clear system for their airway clearance therapy, instead of their previously prescribed therapy. BiWaze Clear is an FDA-cleared respiratory therapy for assisting patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high-frequency oscillation therapies, combined with aerosol delivery. The patient will perform airway clearance with BiWaze Clear as prescribed. The system uses a disposable breathing circuit, which is a single patient use, disposable circuit. The treatment duration is 6 months . The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.

Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

The purpose of this study is to evaluate the efficacy and safety of Lifei Qingchang Granules in the treatment of patients with stable bronchiectasis. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Researchers plan to enroll a total of 150 adult participants (aged 18-75) who have been diagnosed with stable bronchiectasis and experience at least one acute exacerbation in the past 12 months. Participants will be randomly assigned into two groups in a 1:1 ratio: * The treatment group will receive Lifei Qingchang Granules along with standard postural drainage therapy. * The control group will receive a matching placebo along with standard postural drainage therapy. The treatment period will last for 3 months. The main goal is to see if the treatment can improve patients' respiratory symptoms and overall quality of life.

Immune Status and Disease Control of Inflammatory Airway Diseases

The goal of this study is to learn how the body's immune system affects disease control in people with different airway inflammatory diseases.We want to understand: 1.Whether specific immune cell patterns in the blood are linked to how severe the disease is or how well it is controlled. Participants will: 1. Answer questions about their health and symptoms. 2. Give blood samples 3. Have lung function tests and other standard check-ups. 4. share sleep study results. We will compare people with airway diseases to healthy volunteers to see how their immune systems differ.

Clinical Outcomes of BronchiEctaSis in Taiwan: A Multicenter Prospective Cohort (BEST Study)

Bronchiectasis is a disease characteristic by bronchial dilatation. Bronchiectasis leads to further impairment of mucociliary clearance, causing a vicious cycle of further infection and progressive airway damage, resulting in poorer control of the primary disease. The clinical presentation is non-specific. The etiologies of bronchiectasis include post-infection, such as bacterial pneumonia, tuberculosis, or aspiration pneumonia, autoimmune disease, such as rheumatoid arthritis, or sjogren's syndrome, cystic fibrosis and immunoglobulin deficiency. The comorbidities of bronchiectasis include cardiovascular disease, cancer such as lung cancer, or esophageal cancer, gastro-oesophageal reflux disease and iron deficiency anemia. Treating these comorbidities will help for the prognosis of bronchiectasis. The treatment for bronchiectasis included airway clearance therapies, mucoactive medication, long term antibiotics and bronchodilator if indicated. Long term anti-inflammatory therapies are not suggested. Surgery is indicated if medical treatment failure and localized bronchiectasis or massive hemoptysis. The different characteristics of bronchiectasis have been reported in different foreign studies. There were few studies in Taiwan. This is a prospective study to find the characteristics including comorbidities, severity, treatment in stable and exacerbation condition and pulmonary rehabilitation in Taiwan.

Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD

The purpose of this pilot randomized clinical trial is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in patients with ILD (Interstitial lung disease, Idiopathic pulmonary fibrosis, Sarcoidosis), Bronchiectasis and Asthma who have a clinically assessed need for a pulmonary rehabilitation program. The main questions the project aims to answer are: * Will HPR and PTR appeal to a minimum of 30% of the eligble patients * Be greatly accepted (≥70% of participant complete 70% or more of the planned sessions) by patients agreeing to participate in the study * Will PTR and HPR lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care Researchers will compare with a comparable control group who gets usual care (scheduled controls and medication but no exercise intervention) to examine the willingness to be randomized and to get an indication on possible health related effects. Participants will be randomly assigned to one of three groups: 1. A structured supervised group-based PTR (exercise twice a week; each session consists of 35 min. evidence-based exercises and 25 min. of patient education) 2. An individual HPR program (self-initiated physical activity) with motivational and professional counseling once a week (10-15min), supported by a tablet screen 3. A control group receiving usual care (CON)

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis

The aim of this clinical trial is to assess the safety of: * single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I * repeated doses of the study drug CHF6333 in subjects with BE - Part II