Bronchoconstriction

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.

3TR-ABC follows people with severe asthma from the day they start a biologic and keeps following them for three years. It is observational, meaning the study does not decide who gets which drug. Patients begin their biologic through normal clinical channels, according to whatever criteria apply in their country, and the study observes what happens next. The point is to work out why these expensive, highly targeted drugs transform life for some patients and do very little for others. The structure is a platform rather than a single trial. One shared core design sits underneath, and individual studies focused on specific biologics run on top of it, each free to add its own extra measurements while keeping the visit schedule and sampling aligned so results can be pooled. Only patients who have never had a biologic before are enrolled. They are assessed thoroughly at the start, then seen again at 4 weeks, 16 weeks, 52 weeks, and at the 2 and 3 year marks, with additional sampling whenever an exacerbation happens. Some sites collect a core package of samples, others an expanded one. Behind it all is the 3TR Consortium, a collaboration spanning 15 European countries and 69 partners, working across seven immune-driven diseases including asthma, COPD, Crohns disease, ulcerative colitis, multiple sclerosis, lupus, and rheumatoid arthritis. It is the largest immunology project the Innovative Medicines Initiative has funded. The asthma work sits in what the consortium calls work package 8, and its guiding questions are blunt ones what separates a good responder from a non-responder, and can severe asthma actually be pushed into remission rather than merely managed. Participants are sorted after the fact into three groups based on how they did remission, clinical response, and non-response. The blood, tissue, and breath samples collected before anyone started treatment are then compared across those groups, along with how each groups immune activity shifted over time. Healthy volunteers and people with mild or moderate controlled asthma go through the same baseline visit and serve as reference points, giving the researchers a sense of what these markers look like outside of severe disease. Samples feed into multi-omic analysis, which means examining genes, proteins, metabolites and more from the same person to map the biological pathways involved. The main target is a set of baseline markers that predict remission at one year. Remission here has a specific definition an ACQ-5 score below 1.5, lung function after bronchodilator either at or above 80% of predicted or improved by more than 10%, no exacerbations, and no maintenance steroid use across the previous twelve months. The same question is asked again at three years, alongside how marker profiles shift between those who reach remission and those who dont, how each individual response measure behaves, and how physician and patient ratings of treatment benefit compare with the consortiums own composite response measure. Exploratory work applies network and cluster analysis, discriminant methods such as PLSDA, daily FENO readings, and analysis of host and microbiome interaction to hunt for biomarker signatures nobody has identified yet. One cohort within the platform, AIR-BIO-OCT, focuses on patients taking benralizumab and goes a step further into the airway wall itself. Biologics are currently matched to patients through phenotyping that leans on clinical features, oral steroid use, and eosinophil counts in blood, sputum, or lavage fluid. What remains unclear is whether these drugs change airway remodeling, the structural thickening involving smooth muscle and extracellular matrix that tracks with how severe and how persistent the disease becomes. This substudy pairs exhaled breath analysis, using both GC-MS and electronic nose technology to read volatile organic compounds, with omics and with optical coherence tomography imaging, including a polarization-sensitive form of OCT. Endobronchial biopsies alongside the imaging are used to establish whether smooth muscle and matrix actually decrease after six months to a year on benralizumab. The broader hope is a minimally invasive breath-based signature that could flag likely responders before treatment ever starts.

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.

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 effectiveness and safety of different doses of Frevecitinib KN-002 for adults with severe asthma that is not well controlled despite using medium to high doses of inhaled corticosteroids combined with long-acting beta-agonists ICSLABA. This Phase 2 randomized, double-blind, placebo-controlled study aims to understand how well Frevecitinib works and how safe it is over a 12-week treatment period. Participants will be randomly assigned to one of four groups three groups will receive different doses of Frevecitinib delivered via a dry powder inhaler, and one group will receive a matching placebo. Treatment will last for 12 weeks, during which patients will continue their usual asthma therapies alongside the study medication or placebo. During the study, participants will undergo various assessments including lung function tests like pre-bronchodilator FEV1, asthma control questionnaires ACQ-6, peak expiratory flow measurements, and quality of life evaluations AQLQ. Researchers will also collect data on daily asthma symptoms, pharmacokinetics, and markers of airway inflammation such as fractional exhaled nitric oxide. Safety and efficacy will be monitored throughout the 12-week period to evaluate the impact of Frevecitinib on severe asthma symptoms.

This Phase II randomized controlled clinical trial examines the impact of increasing soluble fiber intake with Fruitafit Inulin on the gut microbiome and asthma in children. Participants will complete an ASA 24 dietary recall questionnaire to assess fiber intake and, if eligible, will be assigned to either Fruitafit Inulin or placebo Maltodextrin to reach their target fiber dosage. Participants will complete an Asthma Control Questionnaire, provide blood serum, nasal wash, and fecal samples, and receive counseling from a pharmacist on how to include the study medication in their diet. Three stool sample kits will be collected for microbiome and metabolomic analysis, with samples sent during the study and after the final visit. Study procedures, including the ASA 24 questionnaire, will be repeated at the second visit. The total study time is approximately 30 days. Risks include fecal contamination, discomfort from specimen collection, discomfort with answering some survey questions, and risks associated with blood draws. Participants are compensated for their time and receive a portion of their dietary results. There may be no direct benefit to participants, but the research may help improve understanding of how fiber, diet, the gut microbiome, and asthma are connected and whether asthma may be improved by altering diet.

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.

Frequent acute asthma exacerbations may represent a distinct asthma phenotype and are an important cause of disease progression, reduced quality of life, increased healthcare use, and poor asthma control. Asthma affects 118% of the population worldwide, and the prevalence among adults aged 20 years or older in China is 4.2%, representing about 45.7 million people. An acute asthma exacerbation involves a rapid increase in symptoms such as wheezing, shortness of breath, chest tightness, and cough, together with deterioration in lung function requiring additional reliever medication. Patients with frequent exacerbations may have poorer asthma control, lower quality of life, higher use of inhaled glucocorticoids andor oral hormones, increased CRP and sputum eosinophils, faster decline in lung function, and a greater likelihood of continuing to experience frequent exacerbations. However, frequent exacerbations can occur across different levels of asthma severity, including mild to moderate asthma, and may also occur in patients with good treatment adherence and self-management. Previous studies have reported inconsistent findings regarding asthma severity, disease control, blood and sputum eosinophils, FeNO, viral infection-related biomarkers, asthma duration, age of onset, race, and socioeconomic background as risk factors. The main objectives are to compare the baseline clinical, inflammatory, pathophysiological, comorbid, environmental pollutant, and meteorological exposure characteristics of patients with frequent and infrequent acute exacerbations regardless of asthma severity, and to develop a prediction model for frequent exacerbations. The study will also establish a cohort of patients with frequent acute asthma exacerbations to observe prognosis and response to treatment and identify prognostic factors. The study aims to support early identification of patients prone to frequent acute exacerbations, clarify factors associated with poor prognosis, explore underlying inflammatory and pathophysiological mechanisms, and help provide individualized approaches for treatment and prevention while reducing disease burden, healthcare use, and costs.

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.