Chronic Respiratory Failure

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure PEEP up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

Researchers are evaluating the effects of inhaled nitroglycerin on improving respiratory function in patients with late-stage Chronic Obstructive Pulmonary Disease COPD, especially those experiencing respiratory failure and pulmonary hypertension. The study aims to investigate how this treatment may help by dilating pulmonary arteries to reduce ventilationperfusion mismatch and improve antibiotic delivery to the lungs. This trial is sponsored by Beni-Suef University and includes patients admitted to adult intensive care units. Participants will be randomly assigned to one of two groups. One group will receive the standard treatment for COPD exacerbation, including antibiotics, corticosteroids, and bronchodilators. The other group will receive inhaled nitroglycerin in addition to the standard treatment. The study is designed as a phase 2 and phase 3 trial, with no blinding, and will monitor the effects over several days. During the study, participants will be closely monitored for changes in pulmonary function five days after starting the inhaled nitroglycerin. Researchers will also track the number of days on mechanical ventilation, the dose of vasopressor therapy, reduction in white blood cell count, and mortality rate up to ten days after treatment begins. The study aims to understand the treatments impact on respiratory failure in COPD patients and will continue until December 2025.

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.

Researchers are evaluating how a 12-week daily inhaler therapy combining fluticasone furoate, umeclidinium, and vilanterol affects adults aged 50 to 85 with moderate to severe COPD. The study includes equal numbers of males and females with persistent symptoms and compares those at low and high risk of COPD flare-ups. It aims to understand if this triple therapy improves lung ventilation as measured by 129-Xenon MRI and how this relates to lung function tests. Participants will use a single Ellipta inhaler containing the three medications once daily for 12 weeks, with an optional additional 48 weeks of treatment. They will attend two main visits at baseline and after 12 weeks, with an optional third visit at 48 weeks to assess longer-term effects. The study observes participants responses during and after therapy. During visits, participants undergo various lung function tests including spirometry, plethysmography, oscillometry, and exhaled nitric oxide measurement. They will have 129-Xe MRI scans and chest CT scans before and after bronchodilator use. Questionnaires assessing respiratory symptoms, health status, and exertion are completed, along with a blood draw for inflammatory markers. Researchers measure ventilation defect percentage and lung function changes to evaluate therapy effects over time.

Researchers are studying how blood flow to muscles is controlled and how this changes with age and certain diseases such as chronic obstructive pulmonary disease COPD, sepsis, pulmonary hypertension, and cardiovascular disease. The study focuses on four key pathways that affect blood vessel constriction and dilation Angiotensin-II, Endothelin-1, Nitric Oxide, and oxidative stress. The goal is to better understand how these pathways contribute to reduced blood flow during exercise and whether these changes can be improved. Participants will receive various treatments including exercise tests and drugs that affect blood vessel function, such as Nitric Oxide blockers, antioxidants, receptor antagonists, and other vasoactive agents. These treatments will be given through catheter placements for measurements and infusions. Different groups include healthy young adults, older adults, and patients with conditions like COPD, pulmonary arterial hypertension, heart failure, and hypertension. The study will also evaluate effects before and after exercise training. During the study, participants will undergo tests such as maximum exercise capacity, measurements of blood flow, blood pressure, muscle metabolism, and muscle fatigue using advanced imaging techniques like Nuclear Magnetic Resonance NMR. Researchers will monitor changes in limb blood flow and other outcomes at baseline and one hour after treatments. The study aims to provide detailed insight into how vascular function changes with age and disease and how it responds to various interventions over time.

Researchers are investigating the effects of inhaled nitric oxide iNO on exercise capacity and safety in people with moderate-to-severe chronic obstructive pulmonary disease COPD. The study evaluates two doses of iNO, 10 parts per million ppm and 40 ppm, each administered for at least 2 hours daily over one week. This research aims to find safe and effective treatment methods for COPD, focusing on lung function and exercise performance. Participants are randomly assigned to one of three groups inhaled nitric oxide at 10 ppm, inhaled nitric oxide at 40 ppm, or a placebo treatment using air. Each treatment is inhaled for at least 2 hours per day for 7 consecutive days. The iNO is delivered through a specialized system that ensures a constant concentration during inhalation. The placebo group inhales air with 21% oxygen, mimicking the treatment process without active nitric oxide. During the study, participants undergo cardiopulmonary exercise tests measuring oxygen uptake, ventilation efficiency, and breathlessness scores at the start and end of the 7-day treatment period. Lung function tests, symptom questionnaires, a six-minute walk test, and safety monitoring for adverse events are also performed. The study tracks changes from baseline to day 7 to assess the impact of the treatments on exercise capacity and respiratory health.

Researchers are evaluating inhaled nitric oxide to understand its effects on exercise tolerance and safety in people with moderate-to-severe Chronic Obstructive Pulmonary Disease COPD. This study aims to help develop better treatment options for managing COPD symptoms and improving patient outcomes. The trial is sponsored by Novlead Inc. and does not involve a specific drug phase classification. Participants will be randomly assigned to receive inhaled nitric oxide at either 10 parts per million ppm or 40 ppm. Each participant will inhale the gas for at least 2 hours each day over a period of 7 consecutive days. The nitric oxide is delivered using a specialized device that controls the concentration of gas inhaled through the breathing apparatus. During the study, participants will be closely monitored with various tests and assessments. These include measuring changes in oxygen uptake, breathing efficiency, perceived exertion, lung function, walking distance, and COPD symptom scores, all recorded at the beginning and end of the 7-day treatment period. Safety and treatment effects will be assessed throughout, with the total participation lasting just over one week.

Researchers are evaluating the safety, tolerability, and how the body processes TQC3302 inhalation spray in healthy adults between 18 and 55 years old. This Phase 1 clinical study uses both a single-center, open-label design and a randomized three-sequence, three-period crossover design for different groups. The study focuses on measuring adverse events and drug levels in the body after single and multiple inhalations of TQC3302 and comparator inhalation sprays in healthy participants. Participants receive single doses or multiple doses of TQC3302 inhalation spray alone or combined with other inhaled drugs like Tiotropium bromide and olodaterol hydrochloride inhalation spray or Budesonide Powder for Inhalation. Different dosing schedules cover single doses during days 1 to 7 and two doses during this period. The study groups are randomized to receive these treatments in various sequences to compare safety and pharmacokinetic profiles. During the study, participants undergo detailed safety assessments including monitoring for side effects up to day 14 after dosing. Blood samples are collected at multiple time points to measure drug concentrations and pharmacokinetic parameters like peak concentration, clearance, and half-life. The study also includes physical exams, lung function tests, laboratory tests, chest X-rays, and ultrasound evaluations during screening. The total participation spans from screening through follow-up visits up to 14 days after the last dose.

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.

Researchers are studying ways to improve treatment decisions for smokers who find it hard to quit using medications. This trial compares different approaches including nicotine replacement therapies patches and lozenges, varenicline, and harm reduction products like e-cigarettes. The goal is to find better strategies to help smokers quit by adjusting treatments based on early response. Participants will receive free treatment products for 12 weeks. Initially, they will be randomized to either varenicline or combination nicotine replacement therapy. After 4 weeks, based on their success in quitting, they may continue the same medication or switch to the other option. At 8 weeks, those still not successful may either continue their current medication or switch to e-cigarettes. No products are provided after 12 weeks. The study includes an additional survey at 6 months after the first phone call. All visits and assessments are done remotely, with a total of 8 surveys completed over the 6-month study period. Researchers will measure quitting success at 8 weeks as the primary outcome and assess dependence and longest quit attempt duration at 12 weeks. Participants are monitored through surveys without in-person visits, making participation convenient and accessible.