View clinical trials related to Respiratory Tract Diseases.
Filter by:Phase IIb clinical trial to assess the Immunogenicity and Safety of a HIPRA's Candidate Booster vaccination (PHH-1V) in adults fully vaccinated with the adenovirus vaccine Vaxevria against COVID-19.
The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)
Objectives: To determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD health status with usual care. Hypothesis to be tested: (i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups. Design and subjects: Multi-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A&E. Instruments: Clinical COPD Questionnaire and EuroQol-5D Interventions: Both intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP >5mg/dL. Once CRP has declined to <5mg/dL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered. Communication with Receiving Ward Staffs: Participants in the study may transfer to another departments after treatment/ care in A&E. The following communication would be conducted: - A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A&E. The note would also suggest the investigations for the receiving ward staffs. - Telephone handover about intervention group and investigations of the study, and treatments given in A&E to ward. Main outcome measures: The antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation. Data analysis: Intention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation. Expected results: The intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.
COVID-19 has multiple facets including cytokine storm, thromboembolism and gelatinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious, in which patients succumb to acute respiratory distress syndrome (ARDS). In other severe respiratory disease such as ventilator associated pneumonia (VAP), formation of biofilm in the endotracheal tube causes infection to spread to the lungs, resulting in respiratory decline and high mortality. The development of gelatinous sputum plugs correlates with negative outcome. Both groups of patients still have limited therapy options. BromAc is a potent mucolytic, biofilm degrader, cleaves the glycoproteins of the SARS-CoV-2 virus (antiviral), and down regulates cytokines and chemokine in COVID-19 sputum. The investigators seek to examine the safety and attempt to gain preliminary efficacy of nebulised BromAc in moderate to severe COVID-19 and other mucus producing, severe, respiratory diseases.
Rationale: The most common approach to weaning infants and children is gradual reduction of ventilatory support ("traditional approach"). Alternatively, another approach to weaning is attempted with alternating periods of complete ventilatory support and graded spontaneous breathing with assistance ("sprinting approach"). Both approaches are used randomly in our unit: the decision to use which approach is dependent upon the preferences of the attending physician as described in many observational single center studies. To date, there is no data comparing the safety and efficacy of the "sprinting" approach with more traditional approaches of weaning in children. Hence, numerous issues remain unanswered, including the work-of-breathing during each approach. For this research proposal, we want to measure the work-of-breathing daily, using the traditional approach (the area under the oesophageal pressure - volume curve) and study its correlation with clinical parameters and EMG activity of the diaphragm and intercostal muscles from the moment that the patient is weaned off the ventilator. Objective: The primary objective for this study is to compare for each patient of the work-of-breathing during the "sprinting"approach and the "traditional approach.The secondary objectives for this study are to compare the oesophageal pressure rate and (PRP) and pressure time product (PTP), the PaO2/FiO2 ratio, global and regional distribution of tidal volume measured using electrical impedance tomography (EIT), phase distribution of the respiratory inductive plethysmography (RIP) signal and the EMG activity of the diaphragm and intercostal muscles between the "sprinting"and the "traditional" approach.. Study design: This is a prospective exploratory study with invasive measurements in a 20 bed tertiary paediatric intensive care facility at the Beatrix Children's Hospital/University Medical Centre Groningen. Study population: All mechanically ventilated children aged 0 to 5 years with or without lung pathology admitted to the paediatric intensive care unit are eligible for inclusion. Inclusion criteria include mechanical ventilation for at least 48 hours, weight ≥ 3 kg, sufficient respiratory drive present, deemed eligible for weaning by the attending physician, and stable haemodynamics (defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment). Exclusion criteria include mechanical ventilation less than 48 hours, not eligible for weaning (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 > 0.6 within 6 hours prior to enrolment), unstable haemodynamics (defined by the need for increase in vaso-ative drugs and/or fluid challenges within 6 hours prior to enrolment), leakage around the endotracheal tube > 5%, admitted to the neonatal intensive care unit, preterm birth with gestational age corrected for post-conceptional age less than 40 weeks, congenital or acquired neuromuscular disorders, congenital or acquired central nervous system disorders with depressed respiratory drive, congenital or acquired damage to the phrenic nerve, congenital or acquired paralysis of the diaphragm, use of neuromuscular blockade prior to enrolment, uncorrected congenital heart disorder, and chronic lung disease. Main study parameters/endpoints: The main study parameter is the level and time course of the patient's work-of-breathing mathematically calculated by the area under the pressure-volume curve Secondary study parameters include the level and time course of the PRP and PTP, level and time course of oxygenation (PaO2/FiO2 ratio), global and regional distribution of tidal volume, phase distribution, EMG activity of the diaphragm and intercostal muscles, heart rate, respiratory rate.. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are a priori no specific benefits for the patients who participate in the study.
Development of a new patient reported outcome measure (PROM) that will measure the daily burden of gastrointestinal symptoms over the previous 24 hour period for people with cystic fibrosis.
Objectives and aim: To evaluate the long-term spill-over (indirect) effect of Coronavirus disease (COVID-19) on health outcomes and healthcare utilization among people with non-communicable diseases and without COVID-19. Design: A population-based cohort study using electronic health records of the Hospital Authority (HA) clinical management system, economic modeling, and serial cross-sectional surveys on healthcare service utilization. Setting: HA public hospitals and outpatient clinics in Hong Kong Participants: People aged ≥ 18 years with a documented diagnosis of diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic respiratory disease, and chronic kidney disease; without COVID-19; attending HA services between 2010 and 2024. Main outcome measures: All-cause mortality, disease-specific outcomes, healthcare service utilization, and costs. Methods: The annual incidence of each outcome in each year between 2010 and 2024 will be calculated. An interrupted time-series analysis to assess the changes in outcomes between pre-and-post-COVID-19 outbreak periods. Long term health economic impact of healthcare disruptions during the COVID-19 outbreak will be modeled using microsimulation. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression to evaluate the effect of different modes of care on the risk of the outcomes. Implications: Findings will inform policies and practices on contingency care plans to avoid excessive morbidity and mortality and to assure the quality of care for patients with NCD as part of the territorial response to the health crisis.
Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicity of intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus. The duration of participation in the study for one subject will be 180±14 days after the first dose of vaccine, during which each subject will undergo a screening visit (within a week) and face-to-face visits according to the study plan. Intranasal vaccine administration will be done at day 1 vaccination visits and day 21±2 days on an outpatient basis. During the follow-up visits key vital signs will be assessed, and will collect data on changes in the state and well-being subjects from a previous visit. Subject data will be collected using electronic forms of individual registration cards, as well as with using questionnaires (diaries) filled by the subjects of the study. Immunogenicity will be assessed on day 1, 10, 28, 42 and 90 days. Humoral and cellular immune response will be evaluated.
This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.
Background: Many adults and some children with COVID-19 or acute respiratory infection become critically ill and need advanced life support in the Intensive Care Unit (ICU). Frailty is a medical condition of reduced function and health. Adults with frailty have a lower chance of surviving critical illness. The investigators are still learning about critically ill adults with COVID-19 or acute respiratory infection, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19 or acute respiratory infection. Rehabilitation can help survivors of COVID-19 or acute respiratory infection by improving strength and improve quality of life (QOL). Objectives: The main goal of this research study is to see if patients with frailty have a lower chance of surviving COVID-19 or acute respiratory infection critical illness and more health problems after survival than patients without frailty. The investigators will also study the types of rehabilitation received by patients with COVID-19 or acute respiratory infection. Methods: The investigators will include adults and children with COVID-19 or acute respiratory infection who are admitted to the ICUs that participate in the study. The investigators will gather data about each patient, including before and during their illness. Outcomes: The investigators will collect level of frailty, function, and types of therapy, or rehabilitation received by patients. In adults, the investigators are most interested in learning if frailty influences mortality, or death. In children, the investigators are most interested in whether children with COVID-19 or acute respiratory infection critical illness are more likely to develop frailty. The investigators will also study post-hospital discharge location in survivors (e.g., home, rehabilitation). Relevance: The COVID-19 pandemic is a global public health crisis. It is critical to understand how COVID-19 and other acute respiratory infection critical illness affects groups of people who are at higher risk, and the impact on outcomes that are important to patients, like functioning and QOL. The results will help policy makers plan post-hospital services for survivors, help healthcare workers understand the importance of rehabilitation practice for patients with COVID-19 or acute respiratory infection, and help researchers develop treatments to improve QOL after COVID-19 or acute respiratory infection.