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NCT03201263
Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice. Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes. The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV. The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU. Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio): * PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT); * PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT). Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.
NCT04470258
The number of COVID-19 cases has been growing exponentially, so that the industrialized economies are facing a significant shortage in the number of ventilators available to meet the demands imposed by the disease. Noninvasive ventilatory support can be valuable for certain patients, avoiding tracheal intubation and its complications. However, non-invasive techniques have a high potential to generate aerosols during their implementation, especially when masks are used in which it is virtually impossible to completely prevent air leakage and the dispersion of aerosols with viral particles. In this context, a helmet-like interface system with complete sealing and respiratory isolation of the patient's head can allow the application of ventilatory support without intubation and with safety and comfort for healthcare professionals and patients. This type of device is not accessible in Brazil, nor is it available for immediate import, requiring the development of a national product. Meanwhile, a task force under the coordination of the School of Public Health (ESP) and Fundação Cearense de Apoio à Pesquisa (FUNCAP), with support from SENAI / FIEC and the Federal Universities of Ceará (UFC) and the University of Fortaleza (UNIFOR) advanced in the development of a prototype and accessory system capable of providing airway pressurization through a helmet-type interface, which was called the Elmo System.
NCT04851808
Chronic Respiratory Disease (CRD), particularly asthma and chronic obstructive pulmonary disorders (COPD) are leading causes of mortality and reduced quality of life due to its wide-reported association with other multi-morbidities.There is limited knowledge on the burden of CRD in the rural communities in Bangladesh due to poor awareness on the impact of CRD on quality of life and unavailability of diagnostic facilities due to weaker primary healthcare settings. The study aims to estimate the CRD burden in Bangladesh in a large representative population to draw the attention of policy makers to the creation of social awareness and improvement of primary healthcare infrastructure for respiratory disease in Bangladesh. The study is a prospective observational one in nature. The study will be implemented in Mirzapur, a rural sub-district of Tangail district in Bangladesh within the period of February to May 2021. A total of 981 participants will be enrolled from the study. Verbal consent will be taken initially. Participants who are assessed to be COVID-19 negative will be invited for a visit to the mobile clinic following national health guidelines to perform the spirometry. The study team will provide an information sheet (written in local language) that describes the study aim and objectives with potential risk benefits to the participants. All participants will be enrolled through written consent and satisfactory response to the patient information sheet. The Research Assistant (RA) will collect the relevant metadata such as demographics, information on risk factors, screening questionnaires relevant to asthma and COPD, reported health status and symptoms related to CRD etc. from the participant after obtaining the written consent. Data quality will be ensured by the Field Research Supervisor through checking all the collected information. The enrolled participants will undergo spirometry for the evaluation of their lung function. Spirometry will be collected by trained personnel and will be quality checked by an expert panel at CHRF. Repeated collection will take place in the event if the test results do not pass quality checking. Participant will also be invited to the study clinic within the next 10 days after assessment for any further clinical assessment that is deemed necessary by the study physician. The collected data and spirometry reports will be reviewed to evaluate the CRD patient in terms of their disease. The study will analyse the rate of CRD burden stratified by age, sex, and income group. The productivity loss will be measured in terms of work hours lost due to CRDs.
NCT04737161
This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS. Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
NCT04847375
Covid-19 disease is one of the most important health system challenges which is the result of the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of pharmaceuticals, none has been served as a curative treatment and research is continued to find one or more effective drugs; either palliative or curative ones. One of the most important clinical problems in Covid-19 patients is lung involvement, which may causes significant sequels; leading to a main part of morbidity and/or mortality. Surfactant is one of the drugs that can have valuable effects on the lungs, both by reducing the alveolar surface tension and by exerting immunomodulatory effects. In a previous study by the same team, favorable effects were seen in intubated patients; however, the aim of this study was to evaluate the effect of exogenous nebulized surfactant in the pre-intubation stages of the disease.
NCT04199364
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.
NCT04598581
This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).
NCT04395807
We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.
NCT02808819
The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).
NCT01800994
ASTHMA: Asthma is a chronic inflammatory disorder of the airways in which many different types of cells, and various cellular components. The chronic inflammation causes an increase of the over-responsiveness of the airways, which leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning hours. These episodes, usually associated with widespread but variable block the airway, which is usually reversible either spontaneously or by treatment. Asthma is one of the most common chronic diseases worldwide, posing significant social burden in both children and adults. It is estimated that about 300 million people currently suffer from asthma. The incidence of asthma is universal regardless of the level of development of the country. There is evidence that over the last 20 years the prevalence has increased significantly, specially in pediatric populations. COPD: Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem. It is the fourth leading cause of chronic morbidity and mortality in the United States after heart disease, strokes and acute respiratory infections, while on an annual basis, the disease robs the lives of more than 3,000,000 people around us worldwide. The most worrying is that the impact has been steadily rising, and this dramatic increase in the frequency shows that by 2020 the disease will be the third leading cause of death. In Greece, 8.4% of the population suffers from COPD. Smoking is the leading cause of COPD. However, not all smokers develop the clinical picture of COPD, suggesting that additional factors are involved in manifestation. Further investigation of risk factors for COPD, methods of reducing exposure to these agents and the molecular and cellular mechanisms involved in the pathogenesis remain a major area of research to develop effective treatments that will reduce or prevent the development the disease.
NCT03380429
GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
NCT04626089
The purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
NCT04625985
The purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.
NCT02293499
Asthma is a serious chronic health condition particularly in inner-city adolescents, who suffer disproportionately high asthma-related morbidity and mortality that place heavy economic burdens on families and society. There is a consensus that adverse asthma outcomes can be ameliorated by an individual's active engagement in adequate self-management. This multi-site randomized controlled study proposes to implement and evaluate a peer-led asthma self-management for adolescents (PLASMA) program that has demonstrated its feasibility and preliminary efficacy in a previous study. PLASMA will be implemented in three cities (Buffalo NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric asthma and asthma-related morbidity, and are thus most likely to benefit from the program. PLASMA comprises three main components: (a) peer-leader training; (b) a one-day asthma camp where peer leaders will deliver manualized self-management content recommended by the national guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to evaluate the effectiveness of PLASMA in inner-city adolescents with asthma in improving quality of life (primary outcome), and asthma knowledge, attitudes, outcome expectations, self-efficacy, self-management skills, and asthma control, FEV1 (exploratory outcomes) over time, compared to a control group for whom adult leaders will deliver the same program content; (2) to examine the mediating effects of the exploratory outcomes on quality of life; (3) to examine the moderating effects of personal factors (e.g., age, sex, family support) on the intervention's primary and exploratory outcomes; (4) to evaluate the effects of PLASMA on study outcomes in peer leaders (16-20 years); and (5) to determine the economic impact of the intervention. These aims will be accomplished using a two-group randomized controlled trial with 378 adolescents (12-17 years) from the three cities (126 for each site). A total of 42 qualified peer leaders (14 in each site) will be enrolled based on adult nomination. Eligibility criteria for both peer leaders and adolescent learners include: a current asthma diagnosis; persistent asthma; absence of other chronic or mental illness; inner-city residence; and capability of verbal and written communication in English. Participants will provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-, 12-, and 15-months post-camp (T3-T7). Data will be analyzed using a multi-site hierarchical three-level linear mixed-effects model where level 1 represents repeated measures, level 2 = subject, and level 3 = site. To determine the economic impact of the program, investigator will measure the direct healthcare costs and total costs of the program, and perform net cost analyses for each type of costs. In addition, investigator will estimate cost-effectiveness ratios of the PLASMA group compared with the control.
NCT04200326
This pilot study will use novel technologies to collect information about the patient experience before and early after starting Fasenra (benralizumab) as standard of care for severe uncontrolled asthma in a real-world setting, to determine how the experience changes over time. Any detection of an early, subjective first-dose effect in this pilot study will be further validated in a larger follow-up study.
NCT04324957
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU). There are many scales available which are helpful for assessing behavior, pain, and neurological status of neonates but there is no scale available till now which can help to assess cardio-pulmonary status of neonates.
NCT04824573
The effectiveness of inspiratory muscle training (IMT) and manual therapy approaches added to the IMT program in healthy individuals with hyperkyphosis is uncertain. This study was aimed to determine the effects of manual therapy techniques added to IMT and IMT on pulmonary functions (FVC, FEV1, FEV1 / FVC, and PEF), forward head posture, and hyperkyphosis in healthy individuals with hyperkyphosis. Thirty-five individuals voluntarily participate to study were randomly divided into IMT and manual therapy groups. While all participants received twenty minutes of IMT twice a week for four weeks, manual therapy techniques were applied to the manual therapy group in addition to IMT. Pulmonary functions, forward head posture, and hyperkyphosis were evaluated before and after the treatments with spirometry device; cervical range of joint range of motion measuring device (CROM Deluxe), C0-wall (OWD), and C7-wall distance measurement respectively. Statistical Package for Social Sciences (SPSS 25.0) will be used to analyze the data in the research.
NCT01750411
The mission of SARP is to improve the understanding of severe asthma through the integrated study of the effect of genetics on the clinical and biological features of asthma and to investigate how these change over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.
NCT03478657
Asthma is a chronic inflammatory disease of airways and lungs that results in hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7 years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not successful, the parent/guardian will be able to help instruct the subject on the correct use of the ELLIPTA DPI, for two more attempts. The subjects who will be enrolled in the study will take placebo ELLIPTA DPI once daily. After 28 days subjects will be randomized in 1:1 to receive a questionnaire (Version A and B). After completion of the questionnaire on ELLIPTA DPI ease of use, subject's ability to use ELLIPTA DPI correctly will be re-assessed. Approximately 219 subjects will be screened to participate in the study. The study will be conducted for 28 days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
NCT03850626
The CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT). The aim of this study is to validate the CSMS as a tool to assess the clinical effects of Depigoid AIT, so that the CSMS can be used in future studies as a primary endpoint as well as a comparative parameter.