Bronchiectasis

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 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.

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 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 QT/QTc 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 drug's 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.

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.

This research focuses on chronic inflammatory lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD), and interstitial lung diseases (ILD). These conditions involve inflammation and changes in lung structure with a wide range of symptoms and features. The study aims to analyze various characteristics including clinical, biological, and microbiological traits, as well as respiratory exposures and mechanisms related to airway inflammation, to better understand these diseases beyond their initial diagnosis. The study is a prospective cohort conducted at the University Hospital of Reims, France, including adults aged 18 and older diagnosed with the listed respiratory diseases or healthy volunteers as controls. Participants will be followed over a 10-year period with data collected at inclusion and follow-up visits, while controls will only provide data at inclusion. No specific treatments are given as part of the study; care continues as usual. Throughout the study, information such as demographics, disease history, lung function tests, CT scans, and respiratory sample analyses will be collected and stored in an anonymous database. Researchers will use statistical and machine learning methods to identify patient groups with similar disease patterns and predict disease progression and treatment responses. The study is planned to start in September 2025 with a recruitment period lasting five years and follow-up for a decade thereafter.

Asthma is a common condition marked by breathing difficulties, coughing, and wheezing. Diagnosing asthma relies on identifying airflow obstruction, airway sensitivity, and inflammation, but international guidelines vary in their criteria. This research evaluates how well these guidelines agree in diagnosing asthma and explores additional lung function tests like impulse oscillometry (IOS), which is not commonly included in guidelines but available at the Portsmouth lung function service. The study involves analyzing routine lung function data from patients attending the severe asthma service at Queen Alexandra Hospital in Portsmouth. It compares standard diagnostic tests recommended by international guidelines with IOS, a simple, non-invasive test measuring lung function. The goal is to see if IOS can improve the accuracy and ease of diagnosing asthma in adults. Participants' lung function data will be reviewed using both guideline-based and additional criteria, focusing on how well each method identifies asthma. Outcomes include scores based on international asthma guidelines and numbers related to non-guideline lung function tests, assessed about four weeks after recruitment. The study uses an opt-out consent process and aims to provide insights that may enhance asthma diagnosis and management.

Researchers are evaluating the safety of aerosolized RSP-1502, a drug containing tobramycin and CaEDTA, in people with cystic fibrosis who have chronic lung infections caused by Pseudomonas aeruginosa. This phase 1b/2a study compares different doses of RSP-1502 to an active control treatment to find the highest tolerated dose and assess safety. The study is double-blind, meaning neither participants nor researchers know who receives which treatment during the study. Participants will inhale RSP-1502 or the active control, which is tobramycin inhalation solution, over 14 days. The study includes dose escalation cohorts receiving increasing doses of RSP-1502 combined with a fixed dose of tobramycin, followed by a dose expansion cohort at the maximum tolerated dose (MTD). Treatments are delivered via a nebulizer device designed to administer the medication directly to the lungs. During the study, participants will undergo evaluations including spirometry tests, electrocardiograms, and monitoring for any adverse events from Day 1 through Day 28, which covers the 14 days of treatment and 14 days of follow-up after dosing. Researchers will also analyze drug levels in the body at various time points and monitor for lung exacerbations and safety signals. The total participation period is 28 days per participant.