Bronchiolitis

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.

Researchers are conducting a randomized, double-blind, placebo and positive control Phase Ia clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the SIBP-A16 injection in healthy adults aged 18 to 45. The study focuses on understanding how this injection behaves in the body and its safety profile. It involves healthy volunteers without significant medical conditions to ensure reliable results for the Respiratory Syncytial Virus (RSV) research. Participants will be assigned randomly to different groups organized in five queues, with varying doses of SIBP-A16 injection, placebo, or the active comparator Nirsevimab. The injections will be given either intramuscularly or intravenously in single doses across four different dose levels. Each queue undergoes a 14-day safety observation before the next dose level is administered based on safety committee review. During the study, participants will be monitored for adverse events, serious adverse events, and special adverse events of interest from day one up to 361 days after administration. Blood samples will be collected to measure drug levels over time, including peak concentration and time to peak. Various health assessments like physical exams, vital signs, ECGs, chest X-rays, and lab tests will be performed to ensure participant safety and measure outcomes throughout the nearly one-year follow-up.

Respiratory syncytial virus (RSV) is a common virus affecting children, especially young babies, premature infants, and those with heart or lung problems. It is a leading cause of hospitalization for children under 5 years old globally, with many severe cases and deaths occurring in low- and middle-income countries. This research evaluates the safety of an RSV vaccine called ABRYSVO given to pregnant women and how well it protects their infants from severe RSV infections during the first six months of life, particularly in African and lower-middle income countries where data is limited. Pregnant women will receive either the ABRYSVO vaccine or a placebo in a randomized, double-blind trial. The vaccine contains stabilized RSV prefusion F antigens from virus subgroups A and B. The study will enroll pregnant women at the approved gestational age for vaccination, with participants randomly assigned to receive either the vaccine or placebo in equal numbers. The trial will monitor the safety of the vaccine in mothers and infants and measure how well the vaccine prevents severe RSV lower respiratory tract infections in babies up to 180 days old. Participants will attend antenatal clinics and provide informed consent for themselves and their infants. Researchers will follow the women through pregnancy and delivery, recording any preterm births and birth weights. Infants will be monitored for RSV infections confirmed by laboratory tests, and hospitalizations due to RSV will be tracked up to six months of age. Safety assessments include monitoring adverse events in mothers and babies, with follow-up visits and telephone contacts to ensure comprehensive data collection throughout the trial period.

Researchers are evaluating the LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument for detecting and distinguishing influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients showing symptoms of respiratory tract infections. This test is designed to help in the differential diagnosis of these infections in a professional laboratory setting, but negative results alone should not guide patient management as they do not rule out infection. The study is interventional and involves multiple sites. The trial involves collecting clinical specimens, mainly nasal swabs, from symptomatic patients. These specimens are collected prospectively by healthcare professionals, with up to 40% possibly self-collected under supervision. Nasopharyngeal swabs may also be collected by professionals, especially in children 13 years or younger. The assay uses real-time polymerase chain reaction (RT-PCR) to detect viral RNA directly from dry nasal swabs without the need for nucleic acid extraction. Participants will provide nasal or nasopharyngeal swabs preserved in specific transport media, which are tested on the LIAISON NES instrument within one to two hours of collection. The study measures the diagnostic accuracy and clinical performance of the assay. Specimens are carefully stored and handled to maintain quality. The trial monitors conditions including influenza A, influenza B, RSV, and COVID-19 infections and is expected to complete by May 2025.

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs score’s predictive ability. The total study duration extends until the end of 2026.

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 therapy's impact and participants' experiences.

Researchers are studying the safety and immune response of giving a second dose of the RSVpreF vaccine during later pregnancies, as well as how long protection lasts from a single dose given in an earlier pregnancy. The study involves pregnant participants and their unborn babies, along with nonpregnant participants who received the vaccine before, to understand vaccine effects and immune duration. The trial is a Phase 3 study sponsored by Pfizer focused on respiratory syncytial virus (RSV) infection. The study includes three groups: Cohort 1 consists of pregnant participants who previously received RSVpreF in a Pfizer trial and will get a second dose; Cohort 2 includes pregnant participants who received RSVpreF commercially or in a prior trial, randomized to receive either RSVpreF or a placebo; Cohort 3 involves nonpregnant participants who had RSVpreF during a previous pregnancy and will provide blood samples to assess lasting immunity without receiving new vaccine doses. Infants born to vaccinated pregnant participants are monitored for safety and antibody levels for six months. Participants will attend visits for vaccinations, blood tests, and health monitoring. Pregnant participants are observed for reactions and side effects from the day of vaccination through weeks afterward. Infants are followed from birth up to six months to assess adverse events and antibody presence. The main outcomes include reports of vaccine reactions, adverse events, and the level of RSV antibodies at birth and up to six months. Nonpregnant participants provide blood samples to measure immune response persistence over time. The total study duration extends until February 2028.

Researchers are studying the safety and effectiveness of Deurremidevir Hydrobromide oral suspension in infants and young children aged 1 to 36 months who have respiratory syncytial virus (RSV) infection. This Phase III randomized, double-blind, placebo-controlled trial aims to understand how this investigational drug affects RSV symptoms and disease recovery compared to placebo. The trial is sponsored by Simcere Pharmaceutical Co., Ltd and will enroll about 498 participants. Participants will be randomly assigned in a 2:1 ratio to receive either Deurremidevir Hydrobromide (called SIM0916) or a placebo. The drug dose is adjusted by weight, given at 20 mg per kilogram three times daily for five consecutive days, totaling 15 doses. The study monitors participants through this treatment period, comparing outcomes between the drug and placebo groups. During the study, infants and children will be regularly assessed for RSV-related clinical signs and symptoms, including wheezing and cough, using scores like the Wang Bronchiolitis Score. Researchers will track recovery times and the need for intensive care or respiratory support. Safety and symptom resolution will be followed up to day 26 after the first dose. The total participation duration covers screening, treatment, and follow-up assessments to evaluate the drug's impact and monitor safety.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy (SBRT) to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.