Asthma

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.

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.

The purpose is to learn whether the over-the-counter amino acid supplement 5-hydroxytryptophan 5HTP, isolated from the plant Griffonia Simplifolia, can reduce allergic lung responses, improve lung function, and reduce anxiety and depression symptoms in children with allergic asthma. Participants will be randomly assigned to receive either 5HTP or a placebo and will later crossover to the other group. There are 5 study visits over about 12 weeks. The primary outcome is the change in FEV1. The investigators anticipate that 5HTP at the proposed doses will improve lung function as seen in preclinical studies using clinically relevant 5HTP. Other outcomes include blood eosinophil counts, eosinophil numbers in nasal fluid, lung inflammation, and changes in anxiety and depression scores measured using CES-DC and SCARED questionnaires. The study also examines whether 5HTP increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid 5-HIAA, and dopamine. The results have the potential to influence approaches to improve lung function and asthma-associated anxiety and depression.

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 BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

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.

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.

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.