Pulmonary Disease

Researchers are evaluating whether the Breathlessness diagnostics in a Box BiaB tool can shorten the time to diagnosis for patients experiencing breathlessness compared to usual care. This prospective, interventional study uses a stepped-wedge cluster design in general practice settings across the Netherlands, Spain, and Portugal. The main goal is to see if BiaB speeds up diagnosis, with secondary aims to identify more cases of chronic obstructive pulmonary disease COPD and cardiovascular disease CVD, and to assess the tools usability and efficiency. The study involves 45 general practice sites that start with a usual care period and sequentially transition to using the BiaB tool. Patients receive care as part of their regular visits, either through standard diagnostic procedures or with support from BiaB. No additional treatments are mandated by the study. Each site participates for 40 weeks, and data are gathered from routine clinical visits, electronic medical records, and questionnaires completed by patients and healthcare professionals. Participants attend a single study visit and may complete up to four quarterly questionnaires over a follow-up period lasting up to one year. Researchers measure the time from first presentation of breathlessness to diagnosis, the number of new COPD and CVD diagnoses, and the usability of the BiaB tool. Data are collected continuously during the usual care and intervention phases, allowing comparison of outcomes between these periods.

Smoking negatively affects many organs and gradually worsens health, especially lung function. It causes mild airway obstruction and slows lung growth, impacting breathing and overall quality of life. This study evaluates balloon-blowing exercises combined with abdominal and lumbar core muscle activation positions to see if they can improve lung function and quality of life in smokers. Participants will be randomly assigned to one of two groups one will perform balloon-blowing exercises with abdominal and lumbar core muscle activation three times a week for four weeks, supervised by a physical therapist. The other group will perform diaphragmatic breathing exercises with the same frequency and duration. Both interventions last four weeks, with measurements taken before and after. Participants will undergo evaluations of lung function including forced vital capacity FVC, forced expiratory volume in one second FEV1, peak expiratory flow PEF, dyspnea levels, oxygen saturation, and quality of life assessments. These measures will be collected at the start and end of the four-week period to monitor changes and effects of the exercises on respiratory health.

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure PEEP up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

Researchers are evaluating the effects of inhaled nitroglycerin on improving respiratory function in patients with late-stage Chronic Obstructive Pulmonary Disease COPD, especially those experiencing respiratory failure and pulmonary hypertension. The study aims to investigate how this treatment may help by dilating pulmonary arteries to reduce ventilationperfusion mismatch and improve antibiotic delivery to the lungs. This trial is sponsored by Beni-Suef University and includes patients admitted to adult intensive care units. Participants will be randomly assigned to one of two groups. One group will receive the standard treatment for COPD exacerbation, including antibiotics, corticosteroids, and bronchodilators. The other group will receive inhaled nitroglycerin in addition to the standard treatment. The study is designed as a phase 2 and phase 3 trial, with no blinding, and will monitor the effects over several days. During the study, participants will be closely monitored for changes in pulmonary function five days after starting the inhaled nitroglycerin. Researchers will also track the number of days on mechanical ventilation, the dose of vasopressor therapy, reduction in white blood cell count, and mortality rate up to ten days after treatment begins. The study aims to understand the treatments impact on respiratory failure in COPD patients and will continue until December 2025.

This study evaluates whether a mobile phone-based mHealth Behavioural Change Communication BCC educational intervention can improve the adoption and exclusive use of Liquid Petroleum Gas LPG for cooking among households in semi-rural Bangladesh. Household air pollutants HAP from biomass fuels such as wood, agricultural residue, and cow dung expose almost 3 billion people worldwide, including 89% of people in Bangladesh. In the earlier GEOHealth study, 24 months of LPG use reduced personal PM2.5 exposure by about 58.2% and produced changes in innate immune and inflammatory responses, while chronic cardio-pulmonary markers remained relatively stable. More than 70% of households continued using LPG after the earlier study, although not exclusively. The investigators will conduct a large household-level randomized controlled trial using an mHealth-based educational intervention and will continue following the cohort. The study will examine the long-term effects of HAP reduction on subclinical measures of cardiovascular and pulmonary dysfunction, innate and inflammatory immune function, and antibody response to vaccines. Personal 24-hour and area-wise 5-day exposure to PM2.5 and black carbon will be repeatedly assessed before and after the intervention. Lung function and lung pathology will be assessed using spirometry, Chest X-ray, and high-resolution computed tomography of the chest. Cardiovascular measures will include blood pressure and EKG, while metabolic dysfunction will be assessed using HbA1c and fasting lipid profile. Immune function will be evaluated through immune cell phenotyping, functional cytotoxic killer cells, and oxidative stress of lymphocytes.

Researchers are evaluating how a 12-week daily inhaler therapy combining fluticasone furoate, umeclidinium, and vilanterol affects adults aged 50 to 85 with moderate to severe COPD. The study includes equal numbers of males and females with persistent symptoms and compares those at low and high risk of COPD flare-ups. It aims to understand if this triple therapy improves lung ventilation as measured by 129-Xenon MRI and how this relates to lung function tests. Participants will use a single Ellipta inhaler containing the three medications once daily for 12 weeks, with an optional additional 48 weeks of treatment. They will attend two main visits at baseline and after 12 weeks, with an optional third visit at 48 weeks to assess longer-term effects. The study observes participants responses during and after therapy. During visits, participants undergo various lung function tests including spirometry, plethysmography, oscillometry, and exhaled nitric oxide measurement. They will have 129-Xe MRI scans and chest CT scans before and after bronchodilator use. Questionnaires assessing respiratory symptoms, health status, and exertion are completed, along with a blood draw for inflammatory markers. Researchers measure ventilation defect percentage and lung function changes to evaluate therapy effects over time.

This NIH-sponsored study aims to characterize three biomarkers derived from 129Xe gas exchange MRI and understand how they change in response to interventions. The study focuses on markers derived from the interaction of 129Xe with pulmonary capillary red blood cells RBCs, specifically RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift. The study population includes healthy volunteers, patients scheduled to undergo transfusion or phlebotomy, patients with dyspnea, interstitial lung disease ILD, idiopathic pulmonary fibrosis IPF, non-specific interstitial pneumonias NSIP, chronic hypersensitivity pneumonitis cHP, sarcoid, chronic thromboembolic pulmonary hypertension CTEPH, and acute pulmonary embolism.

Researchers are evaluating the use of 18F-Fibroblast Activation Protein Inhibitor 18F-FAPI-74 positron emission tomography PET as a noninvasive biomarker to assess lung disease and fibrosis in patients with active tuberculosis TB. The study focuses on microbiologically confirmed TB patients to determine if 18F-FAPI-74 PET can detect fibrosis in TB lesions with high sensitivity. Participants will receive a single intravenous dose of 18F-FAPI-74 followed by a PETCT scan performed either during the first six weeks of TB treatment or within six weeks after completing six months of TB treatment. Some patients may have a second PETCT scan after treatment completion to compare findings. This process allows assessment of fibrosis at different stages of TB treatment. During the study, participants will undergo whole-body PET scans after injection of 18F-FAPI-74, with imaging correlated to sites of TB lesions identified on computed tomography CT. Researchers will measure the uptake of 18F-FAPI-74 using standardized uptake values within one hour. Participants will provide informed consent and comply with scheduled visits and procedures. Safety and laboratory tests will be monitored throughout the study.

This trial tests whether handing patients a combination inhaler as they leave the emergency room reduces how often their asthma flares again over the following three months. The reasoning starts with a gap in current practice. Asthma attacks send about two million people to US emergency departments each year. Most are treated and sent home, but roughly one in six comes back for more care on the same episode. Adding an inhaled steroid at discharge has looked promising since a 2000 Cochrane analysis of three trials, where the benefit was real but fell just short of statistical significance. Even so, uptake never took hold. Emergency clinicians hesitate to start what feels like a lifelong maintenance drug, and patients tend to give up on a steroid-only inhaler because it does nothing for symptoms in the moment compared with their familiar albuterol. Airsupra sidesteps both objections by combining albuterol and budesonide in a single device, which makes the emergency department a plausible place to start inhaled steroid therapy for the first time. Rather than randomizing individual patients, the study randomizes hospitals. Thirty emergency departments are split into two groups of fifteen, balanced by US region so the halves look alike at baseline. At intervention sites, enrolled patients go home on a short oral steroid course, such as prednisone 50 mg daily for five days, plus Airsupra to use as their rescue inhaler. Control sites treat patients however they normally would. Everyone receives a short asthma education handout. Enrollment runs through the Multicenter Asthma Research Collaboration, part of the Emergency Medicine Network founded in 1996 for exactly this kind of research. Massachusetts General Hospital coordinates the study from Boston but does not enroll patients itself. In broad terms, participants are adults aged 18 to 54 whose emergency physician has decided to discharge them on a short steroid course. Data collection happens on two tracks. In the emergency department, staff conduct a brief structured interview and a focused chart review using instruments developed for earlier asthma studies, entering everything into a central REDCap database. Afterward, patients are contacted at about three, six, and twelve weeks, usually by phone and sometimes by text, to discuss symptoms, medication use, and any side effects, with asthma control scored on a ten-item questionnaire called the AIRQ. Separately, patients sign releases so the Boston team can gather medical records covering the year before enrollment and the three months after, pulled from the enrolling hospital, the primary care provider, and any allergist or pulmonologist involved. Those records are what confirm repeat flares and document what medications patients are taking at the three-month mark. The main question is recurrence, meaning any urgent or unscheduled visit to a clinician for worsening asthma within three months of the original emergency visit. That is deliberately broader than the usual three-week relapse window, since symptoms typically settle within one to two weeks while the underlying inflammation takes closer to three. Nobody knows the true recurrence rate in this population, but the investigators expect around 33% under usual care, combining early relapses with additional flares across the autumn and winter weeks that follow. Asthma control at three months is the leading secondary question, alongside three-week relapse and whether patients start Airsupra at any point during follow-up. On the statistical side, recurrence is analyzed as time-to-event data, unadjusted and then adjusted for demographics such as age, sex, race and ethnicity, and insurance, plus any clinical factor showing an association at P<0.20. Three-month asthma control is compared with a t-test or Mann-Whitney U-test, and repeated measures arent needed because baseline control is meaningless during an active attack. There is no interim analysis, given the short enrollment period and Airsupras established safety record. Detecting a one-third reduction in recurrence, 22% versus 33%, requires 1,290 patients. Allowing for 70% follow-up, the target was raised to 1,860, or 930 per arm and 62 per site. Based on three decades of experience with this network, each site should reach that number within a four to five month enrollment window running from August to December.

Researchers are evaluating the safety, tolerability, and early effects of 4D-710, an investigational gene therapy, in adults with cystic fibrosis CF lung disease who cannot use or tolerate existing CFTR modulator therapies. A sub-study also includes adults with advanced CF lung disease or frequent lung flare-ups who are currently on CFTR modulator therapy. This Phase 12 open-label trial aims to find appropriate dosing and assess potential benefits for these patient groups. Participants receive a single inhaled dose of 4D-710, which is a gene therapy designed to deliver a corrected version of the CFTR gene to lung cells. The study includes a dose exploration phase for those ineligible for modulator therapy, a dose expansion phase at selected doses, and a sub-study for participants on modulator therapy receiving various doses. Each participant undergoes one administration of the therapy during the trial. Throughout the study, participants are monitored for adverse events over a 60-month period. Evaluations include lung function tests, oxygen saturation measurements, and tracking of pulmonary exacerbations. Participants maintain their existing treatments if applicable, and researchers assess safety and early signs of effectiveness. The total study duration extends up to approximately nine years, including long-term observation after dosing.