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NCT07192705
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.
NCT06872892
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.
NCT07490704
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.
NCT06166056
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
NCT02779478
A biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary Non-tuberculous mycobacteria (NTM) disease. In a cohort of 200 subjects suspected of having pulmonary NTM disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. Since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.
NCT07063290
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing fiberoptic bronchoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing fiberoptic bronchoscopy under propofol sedation.
NCT06361121
The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL) Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks. In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries. In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions.
NCT07274631
Chronic inflammatory pulmonary diseases, including asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD) and interstitial lung diseases (ILD) are characterised by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognostic features are highly variable and heterogeneous. Several phenotypes have been described within the same pathology, as similar phenotypic traits between different pathologies, or the coexistence of components of several diagnoses in the same patient, suggesting shared underlying mechanisms that could represent new therapeutic targets, beyond the initial medical diagnosis. The objectives of this prospective study are to analyze the phenotypic characteristics (clinical, demographic, biological, morphological, pathological, and microbiological characteristics) together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes in a cohort of patients diagnosed with asthma, COPD, bronchiectasis, CF, PCD and ILD.
NCT06280391
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.
NCT07188675
Bronchiectasis is a chronic respiratory disease clinically characterized by recurrent pulmonary exacerbations, chronic cough, and sputum production, and is associated with an increase in the airway-artery ratio and permanent airway dilatation. It is recognized as the third most common chronic respiratory disease after chronic obstructive pulmonary disease (COPD) and asthma. In the International Classification of Diseases and Related Health Problems (ICD-10), it has its own diagnostic code (J47.9). In bronchiectasis, mucociliary clearance is impaired due to bronchial dilatation, and the insufficient clearance of bacteria and mucus from the respiratory tract leads to persistent infection, inflammation, and further airway damage. Progressive airway damage results in impaired lung function, worsening of symptoms, and, ultimately, respiratory failure and death. It can represent the final pathway of various infectious, allergic, inflammatory, genetic, and degenerative disorders, making it one of the most complex and heterogeneous syndromes. Some patients present with daily symptoms, while others remain asymptomatic except during exacerbations. The most common symptom is chronic cough caused by purulent or mucopurulent sputum. Other symptoms include dyspnea, pleuritic chest pain, wheezing, fatigue, and weight loss. Fever, however, is not a common finding and differs from pneumonia. The most frequently used classification system categorizes bronchiectasis into varicose, cylindrical, and saccular (cystic) types. In the most severe form, the saccular type, the bronchi lose their structural integrity completely, forming cystic structures filled with secretions. The mildest form is cylindrical, in which the bronchi have thick, straight walls. In the varicose type, localized narrowings are observed. Diagnosis is made following history and physical examination, with high-resolution computed tomography (HRCT) being the most sensitive and specific method, along with sputum culture and chest radiography. The goals of bronchiectasis treatment are to manage symptoms, prevent complications, and improve quality of life. Both pharmacological and patient-managed interventions are commonly applied. Pharmacological treatments include antibiotics, bronchodilators, and corticosteroids, which are generally administered via inhalation. Patient-managed interventions require active participation and behavioral modification. Within published guidelines, airway clearance techniques are widely described under pulmonary rehabilitation (PR), but there is no consensus regarding PR itself. For individuals with reduced exercise tolerance, participation in PR and engagement in physical activity are recommended. However, research has shown that referral rates to PR are often low, and exercise and physical activity are not consistently prescribed. Within PR, techniques such as the active cycle of breathing techniques (ACBT), postural drainage, thoracic expansion exercises, and various airway clearance methods are applied, with inspiratory muscle training (IMT) forming an important component. Functional inspiratory muscle training (FIMT) is an IMT program developed by considering not only the ventilatory roles of the respiratory muscles but also their non-respiratory functions. FIMT integrates inspiratory muscle training with core stabilization and postural control exercises. The rhythmic co-contractions of the muscles in the core region support trunk stability and provide the basis for movement. In the first stage of the program, participants receive IMT, and subsequently, core stabilization training and dynamic trunk activation exercises are incorporated into the intervention. A review of the literature reveals that no studies have investigated the effectiveness of FIMT in adults with bronchiectasis. In our study, we aim to evaluate the effects of FIMT, applied in addition to home-based chest physiotherapy, on pulmonary function, diaphragm thickness, balance, core stability, functional capacity, physical activity, posture, and quality of life in adults with bronchiectasis. Furthermore, we aim to compare these outcomes with those of IMT applied alongside home-based chest physiotherapy. We believe that this approach will contribute to the development of treatment strategies in clinical practice and help address existing gaps in the literature.
NCT07346625
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.
NCT07289464
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.
NCT07317531
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.
NCT07313904
This study is a prospective, observational study of patients aged 18-80 years with clinical diagnosis of bronchial asthma, allergic bronchopulmonary aspergillosis (ABPA), bronchiectasis and healthy subjects. Among them, the bronchial asthma group will be divided into asthma control group, asthma partial control group and asthma uncontrolled group according to the GINA asthma control classification. Record the baseline information of the subjects in detail, including basic information, disease course, smoking, previous acute attacks and hospitalizations, long-term medication, etc. (including the frequency, dose and duration of ICS use, antifungal drug type, dose, duration of use, and course of treatment), and evaluate and record environmental factors (such as indoor).Humidity, temperature, ventilation, pet keeping, plant planting, etc.) and other lifestyle factors that may affect disease control and fungal exposure. The patient's disease status was assessed using questionnaire scores. Sputum samples were taken at the time of enrollment.Set (asthma ABPA group uses sputum induction), pulmonary function test and bronchodilator test, FeNO measurement (asthma ABPA group only), blood routine test, Aspergillus-specific IgE and IgG detection, total immunoglobulin IgE, allergen detection, etc. Dust was collected indoors (bedrooms), outdoor (balconies) and on the surface of air conditioners or fans (if applicable) in the subject's living environment, and environmental data such as ambient temperature, humidity, and particulate matter concentration were recorded. 18S rRNA technology was used for sputum and dust fungus detection, and ELISA was used for asthmatitis symptomatic markers, which assess the impact of fungal infections on the disease. Follow-up for each subject 6 months, 6 months after enrollment, the patient's symptom changes, acute exacerbations/exacerbations, and prognosis were recorded, and relevant questionnaire scores were completed.
NCT07291167
Bronchiectasis is a common lung disease. Approximately 20-40% of patients with bronchiectasis experience comorbid anxiety and depression. Multiple studies have now demonstrated that anxiety and depression are associated with an increased risk of disease exacerbation in these individuals. Therefore, this study aims to collect data on anxiety and depression status, disease exacerbation frequency, hospitalisation rates, and mortality among participants diagnosed with bronchiectasis. Concurrently, biological samples including blood, sputum, and stool will be obtained. Through metabolomics analysis, we will investigate the expression of anxiety and depression-related metabolic pathways and identify corresponding biomarkers to explore their role in the progression of bronchiectasis.
NCT04594369
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
NCT06670937
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.
NCT07263373
Bronchiectasis is a heterogeneous condition with diverse etiologies and clinical manifestations. Its progression involves a vicious cycle of airway inflammation, recurrent infection, and structural damage, leading to persistent symptoms and declining lung function. Current management focuses on airway clearance and antibiotics, with no disease-modifying therapies available. Recognizing this heterogeneity is crucial for advancing targeted treatments and precision medicine. Radiomics converts medical images into mineable data to reveal underlying pathophysiology. While applied in other respiratory diseases, its potential in bronchiectasis remains underexplored. Both radiomics and the lung microbiome are independently linked to disease severity in conditions like COPD, but their interplay is unclear. Integrating these modalities with clinical data could unlock novel insights, identify new therapeutic targets, and improve diagnostic and prognostic models. However, few studies have investigated multimodal models combining radiomics, microbiome, and clinical features to predict outcomes in bronchiectasis. To address this gap, we designed a multicenter, retrospective study. It will analyze data from patients diagnosed between January 2020 and July 2025 to evaluate the combined value of radiomics, microbial features, and clinical parameters in diagnosing and predicting the progression of bronchiectasis.
NCT07147803
Non-cystic fibrosis (non-CF) bronchiectasis is a chronic, heterogeneous airway disease characterized by irreversible bronchial dilatation, persistent airway infection, and neutrophilic inflammation that together drive daily cough, sputum production, recurrent exacerbations, and progressive functional decline. Sleep is a key determinant of Health-Related Quality of Life (HRQoL) and cardiometabolic health. In chronic lung diseases, nocturnal hypoxemia, cough, dyspnea, and systemic inflammation commonly disrupt sleep continuity and architecture. In bronchiectasis specifically, several studies show high rates of poor sleep quality using the Pittsburgh Sleep Quality Index (PSQI), with \~50-60% of clinically stable patients classified as "poor sleepers," often accompanied by daytime dysfunction. Poor sleep correlates with disease severity indices and symptoms such as nocturnal cough.
NCT06344000
Bronchiectasis is a common lung disease. The Bronchiectasis Severity Index (BSI) is a widely used assessment system. The body mass index (BMI) is a commonly used measure of nutritional status, but it has its limitations. To provide a more comprehensive assessment, the investigators also consider other nutrition-related indices such as upper arm circumference, calf circumference, skinfold thickness and grip strength. The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants' disease progression.