Bronchiectasis

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.

This prospective, open-label, multicenter, single-arm, non-interventional, observational surveillance is designed to assess the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice. Three different doses of Atectura inhalation capsule will be prescribed via Breezhaler according to the approved label information in Korea. No additional diagnostic or monitoring procedures will be conducted specifically for this study.

Researchers are evaluating the safety, tolerability, and how the body processes RSS0343 after multiple oral doses in healthy adults aged 18 to 55 years. This phase I clinical trial also monitors the effects of RSS0343 on heart electrical activity, specifically the QTQTc interval. Participants will receive either RSS0343 tablets or placebo tablets, taken orally, in a randomized and double-blind manner. The study observes the effects over a 28-day period, assessing the drugs concentration in the blood at various times and its elimination from the body. During the study, participants will undergo physical exams, vital signs checks, lab tests, and heart monitoring. Researchers will track any adverse events, measure drug levels in blood and urine, and monitor changes in heart rhythm. The study includes close safety monitoring throughout the 28-day evaluation period.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

The PALMIRE project is a prospective, monocentric study conducted at the University Hospital of Reims, France, involving patients diagnosed with chronic inflammatory pulmonary diseases including asthma, chronic obstructive pulmonary disease COPD, bronchiectasis, cystic fibrosis CF, primary ciliary dyskinesia PCD, and interstitial lung diseases ILD. These diseases are characterized by lung inflammation and remodelling, with highly variable clinical, functional, microbiological, biological, pathological, and prognostic features. The study aims to analyze phenotypic characteristics, including clinical, demographic, biological, morphological, pathological, and microbiological features, together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes. It also considers shared phenotypic traits between different diseases and the coexistence of components of several diagnoses in the same patient, which may suggest shared underlying mechanisms and possible therapeutic targets beyond the initial medical diagnosis.

Researchers are comparing how two different forms of the study medicine GSK5784283 are processed in the bodies of healthy adults. This phase 1 study aims to understand the pharmacokinetics of GSK5784283, evaluating its safety, how well it is tolerated, and whether the two formulations behave similarly in the body. Participants will receive one of two versions of GSK5784283 by injection. The study is randomized and parallel in design, meaning participants are assigned to either the test or reference formulation without switching. The research includes monitoring blood levels of the drug over time to assess concentration and exposure. Participants will be involved in regular monitoring up to 253 days after dosing. This includes blood tests to measure drug levels, assessments for side effects or adverse events, laboratory tests, vital signs, and heart monitoring using ECGs. Researchers will also check for immune responses to the drug through antibody testing, ensuring comprehensive safety and effectiveness evaluations during the study period.

The aim is to assess how closely international asthma guidelines agree in diagnosing asthma and to explore additional evidence of airways disease using physiologic criteria such as impulse oscillometry IOS, which is not included in current guidelines but is available through the Portsmouth lung function service. Asthma diagnosis is based on indicators such as airflow obstruction, airway sensitivity, and inflammation, but guidelines from NICE, GINA, and BTSSIGN use different diagnostic criteria, which can lead to inconsistencies in identifying patients with asthma. IOS is a simple, non-invasive lung function test that may improve the accuracy and ease of asthma diagnosis, although evidence for its use in adults remains limited. Routine outpatient lung function data from patients attending the severe asthma service at Queen Alexandra Hospital in Portsmouth will be analysed using an opt-out consent process. The analysis will focus on the usefulness of IOS compared with other lung function indices in diagnosing asthma. The findings may help refine asthma diagnostic methods and potentially expand the diagnostic toolkit to include IOS, improving the precision and ease of asthma diagnosis and management.

Acute respiratory failure is a serious medical emergency that can quickly lead to death without prompt treatment. Researchers are evaluating a new portable device designed to provide Continuous Positive Airway Pressure CPAP support outside of hospital settings. This device aims to be easy to use by non-medical individuals and to improve outcomes for patients experiencing respiratory failure. The study will test the devices effectiveness and usability in two groups healthy elderly adults who will self-apply the device, and hospitalized patients with mild oxygenation impairment. The device is designed to deliver positive end-expiratory pressure PEEP between 4 and 7.5 cmH2O, and its performance will be assessed in real-world clinical settings across three hospitals. Participants will be monitored for up to 2 hours during device use, with assessments including how easy the device is to use, duration of proper pressure delivery, battery consumption and duration, and changes in blood oxygen levels SpO2. The study will collect data to support the devices future use as a first-aid tool for respiratory failure outside hospitals. The total study duration and follow-up details are not specified.

Coughing is a common and distressing symptom for people with interstitial lung disease ILD, affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapys impact and participants experiences.