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 tool's 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 ventilation/perfusion 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 treatment's impact on respiratory failure in COPD patients and will continue until December 2025.

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are evaluating new imaging techniques in adults aged 18 to 85 with lung diseases such as asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM). The study aims to develop tools for analyzing lung function and structure using hyperpolarized Xenon 129 MRI alongside pulmonary function tests. This research is supported by Western University, Canada. Participants will undergo a series of tests during a one to two-hour visit, including medical history review, vital signs measurement, full pulmonary function testing following American Thoracic Society guidelines, proton MRI, specialized 129-Xe MRI scans using chest coils, and a low-dose thoracic CT scan. The MRI procedure includes monitoring heart rate and oxygen levels, providing hearing protection, and offering supplemental oxygen as needed. These imaging and testing methods help assess lung ventilation, diffusion, and gas exchange. During the study visit, participants will complete pulmonary function tests such as spirometry, plethysmography, and diffusing capacity tests. They will undergo magnetic resonance imaging with hyperpolarized Xenon gas to visualize lung airways and anatomy, along with CT scans matched to MRI breathing maneuvers. Researchers will measure ventilation defect percent (VDP), apparent diffusion coefficients (ADC), and dissolved phase spectroscopy over five years. Participant safety is monitored throughout the visit, and the total study duration includes these assessments and follow-up measures.

Researchers are studying biomarkers from 129Xe gas exchange MRI to understand how they change with different medical interventions. The study focuses on interactions between 129Xe and red blood cells in the lungs. Participants include healthy volunteers and patients with conditions like interstitial lung disease, pulmonary hypertension, acute or chronic pulmonary embolism, anemia, polycythemia, and dyspnea. The study uses hyperpolarized xenon gas inhaled in multiple doses followed by breath holds, alongside oxygen administration. Participants are grouped by treatment: those undergoing transfusion or phlebotomy, patients receiving oxygen for lung-related conditions or healthy volunteers, and those recently diagnosed with acute or chronic pulmonary embolism. Treatments and responses are monitored at baseline and various follow-up points. Participants will undergo MRI scans to measure red blood cell transfer, chemical shifts after oxygen delivery, and changes in red blood cell signal oscillations before and after treatment. The study includes visits up to 3–6 months after interventions to track changes. Researchers also monitor safety and participant adherence throughout the study, which lasts until mid-2028.

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 PET/CT 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 PET/CT 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.

Researchers are evaluating the effect of starting Airsupra inhaler treatment in emergency departments (ED) on reducing acute asthma recurrence and other related outcomes over three months. The study focuses on adults aged 18 to 54 who visit the ED for asthma exacerbations and are discharged with a short course of systemic corticosteroids. This trial is a cluster randomized, open-label study comparing Airsupra use to usual care across multiple centers. Participants will be assigned by site to either receive usual care or Airsupra as their rescue inhaler along with corticosteroids. Airsupra dosing is as needed, with up to six doses per day. The study will run for about four to five months of enrollment per site, with follow-up assessments conducted at approximately 3, 6, and 12 weeks after the ED discharge to monitor asthma control, relapse, and recurrence. During the study, patients will complete interviews and chart reviews in the ED, and follow-up will include telephone or text contact to assess their clinical status and medication use. Medical records from before and after enrollment will be reviewed to identify asthma exacerbations. The main outcome is asthma recurrence within three months, with asthma control and early relapse also measured. Participants’ data will be securely managed throughout the study period, which extends up to 12 weeks post-ED visit.

This research aims to evaluate the safety, tolerability, and early effectiveness of 4D-710, an investigational gene therapy, in adults with cystic fibrosis (CF) lung disease who cannot use or tolerate CFTR modulator therapy. It also includes a sub-study to assess this gene therapy in adults with advanced CF lung disease or frequent lung flare-ups while on current modulator treatments. The study is a Phase 1/2, open-label, multicenter trial focused on this population. Participants receive a single inhaled dose of 4D-710, a gene therapy using an adeno-associated virus to deliver a modified CFTR gene. The trial has different groups: those who cannot use modulator therapy will get varying doses to find the best dose for further study, while those on modulator therapy receive selected doses in the sub-study. The treatment is given once, and doses are explored and expanded to identify recommended levels. During the trial, participants are monitored for up to 60 months to track any side effects and overall safety. The main measure is the number and severity of adverse events. Participants will have lung function tests, oxygen level checks, and other health assessments throughout the observation period. The study will gather detailed safety and tolerability data to guide future research on this gene therapy in CF lung disease.