Asthma

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.

The 3TR-ABC study is a large, multicenter observational research project that follows patients with severe asthma starting biological therapy and continues for three years. It aims to understand how patients respond to these treatments by examining clinical features, biomarkers, and immune system mechanisms. The study also includes healthy individuals and patients with mild to moderate controlled asthma as comparison groups to better understand differences in disease and treatment response. Participants with severe asthma who are beginning biological treatments will be assessed at the start of the study and then followed at set intervals: 4 weeks, 16 weeks, 52 weeks, 2 years, and 3 years. The study collects various biological samples for advanced analysis and uses innovative methods such as exhaled breath analysis and imaging technologies in specific sub-studies. The study design allows for additional visits if participants experience asthma exacerbations. Healthy volunteers and those with mild/moderate asthma only have a baseline visit. Throughout the study, participants undergo detailed clinical and biological evaluations including questionnaires, lung function tests, and biomarker sampling. The research team measures asthma control, lung function, frequency of exacerbations, and medication use over time. By tracking these outcomes and analyzing biological data, the study seeks to identify markers linked to treatment remission, response, or non-response. Safety and long-term effects are monitored during the three-year follow-up period.

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.

Researchers are evaluating whether the supplement 5-hydroxytryptophan (5HTP) can improve breathing and reduce anxiety symptoms in children with mild to moderate allergic asthma. This phase 2 study aims to test if 5HTP reduces allergic lung responses, improves lung function measured by Forced Expiratory Volume at one second (FEV1), lowers blood eosinophil counts, and decreases anxiety and depression symptoms. The study is sponsored by Indiana University. Participants will receive either 5HTP or a placebo during two 28-day dosing periods separated by a 3-week washout phase. The 5HTP dose is based on weight: 50mg twice daily for those under 100 lbs, and 100mg twice daily for those over 100 lbs. The study uses a randomized, triple-blind crossover design, meaning participants switch from one treatment to the other during the study. Over about 12 weeks, participants will attend five study visits where lung function tests, blood samples to measure eosinophils, and anxiety/depression questionnaires will be completed. Researchers will monitor changes in lung function, blood markers, and mental health symptoms to evaluate the effects of 5HTP. Safety assessments will ensure participant well-being throughout the study period.

Researchers are observing the safety and effectiveness of Atectura inhalation capsule in people aged 12 to 100 years with asthma over a 24-week period. This non-interventional, open-label study takes place across multiple centers and follows routine clinical practice without additional diagnostic or monitoring procedures beyond standard care. The study aims to gather real-world data on the use of Atectura as prescribed under approved labeling in Korea. Participants will use one of three doses of Atectura inhalation capsule delivered via Breezhaler: 150/80 µg, 150/160 µg, or 150/320 µg of indacaterol acetate/mometasone furoate. Treatments are prescribed by physicians according to routine care, and patients who have already started Atectura before joining the study will be included. No randomization or placebo control is involved since this is an observational study. During the study, researchers will track adverse events and serious adverse events over 24 weeks to evaluate safety. Lung function changes will be measured by trough FEV1 at baseline and week 12, along with asthma control using the ACT score. Effectiveness will also be assessed by investigators at week 12. Patient data on drug reactions and lung function changes will be collected to better understand treatment impact. The study runs until December 2026 and involves regular clinical assessments without extra tests beyond standard asthma care.

Researchers are observing adult patients with asthma who have been prescribed Enerzair inhalation capsules to evaluate the safety and effectiveness of this treatment over a 24-week period in real-world clinical settings. This study is open-label, prospective, multicenter, and single-arm, designed to monitor outcomes without additional interventions beyond routine care. Participants will receive one of two doses of Enerzair via Breezhaler, either 150/50/80 micrograms or 150/50/160 micrograms, as prescribed according to approved labeling in Korea. No extra diagnostic or monitoring procedures beyond standard clinical practice will be conducted during the study. Throughout the study, participants will be monitored for adverse events and serious adverse events for up to 24 weeks. Researchers will also assess lung function using trough FEV1 measurements and asthma control using the ACT score at baseline and week 12. Effectiveness will be evaluated by investigator assessment, and patient characteristics related to safety and efficacy outcomes will be recorded. The study involves collection of data without altering prescribed treatment and ensures ongoing observation in a routine care environment.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are evaluating the effects of increasing soluble fiber intake on the gut microbiome in children aged 6 to 17 with asthma. This Phase II randomized controlled trial aims to understand how diet, specifically fiber intake, may influence asthma symptoms and related biological pathways. Participants will be assessed through dietary recalls and various biological samples to explore connections between diet and asthma control. Participants will be randomly assigned to receive either soluble fiber (Fruitafit Inulin) or a placebo (Maltodextrin). After initial assessments including dietary recall, nasal wash, blood samples, and an asthma control questionnaire, participants will receive counseling on how to include the study product in their diet. Over approximately 30 days, participants will collect and submit three stool samples for microbiome and metabolomic analysis, and repeat assessments at a second visit about 25 days later. Throughout the study, participants will complete questionnaires, provide biological samples including blood, nasal wash, and stool, and undergo dietary intake assessments. Researchers will monitor gut microbiome diversity, asthma control, nasal inflammation, and circulating short-chain fatty acids. The study includes safety monitoring for minimal risks such as discomfort from sample collection and blood draws. Participants receive compensation and partial dietary results, with total involvement lasting about one month.