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NCT03084796
The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.
NCT04834531
This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome (Tan-re Zheng)in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis.
NCT02317042
This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".
NCT04834037
Background: Informative and supportive nursing care is essential to reduce complications and improve outcomes in Chronic Obstructive Pulmonary Disease (COPD) patients treated with Non-Invasive Ventilation (NIV). Objective: Aim of the study is to determine the effect of provision of information and supportive nursing care on blood gas, vital signs, anxiety, stress and agitation levels in COPD patients treated with NIV. Research Methodology: A randomised controlled design was used between September-December 2019. The universe of the study consisted of COPD patients treated with NIV in intensive care unit in a state hospital. A total of 60 patients, composed of 30 interventions and 30 controls, were randomly included in the sample. Provision of information and supportive nursing care was applied to the patients in the intervention group. The data were evaluated with SPSS program. Results: Following the intervention, the findings showed that the provision of information and supportive nursing care has a positive effect on the blood gas, vital signs, anxiety, stress and agitation levels of patients. Conclusions: The provision of information and supportive nursing care is recommended to alleviate anxiety, stress and agitation in COPD patients treated with NIV
NCT03794557
This is a study examining the effect of inhaled PUL-042 on peak lower respiratory symptoms as measured by subject diary in early stage COPD subjects who are experimentally infected with rhinovirus. Subjects will receive 1 dose of PUL-042 followed by inoculation with HRV A16 virus 24 hours later. An additional dose of PUL-042 will be administered 48 hours post-inoculation. Subjects will be followed for 6 weeks post-inoculation
NCT02183818
We aim to use an integrated network systems approach to analyze certain existing small airway epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and metabolomic levels, to develop an initial model of network connectivities and key network pressure points relevant to SAE biology in health and disease.
NCT04725500
This study aimed to validate a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation (EFL). The investigator conducted a prospective, non-randomized, study on stable chronic obstructive pulmonary disease (COPD) patients that may or may not be treated currently with NIV. Patients were studied in a sleep lab on a single night with the auto - titrating EPAP that adjusts to abolish tidal EFL. The primary endpoint was to evaluate the behavior of the EPAP during the night. Additionally, a sub-group of patients used the device at home for a 2 week period. EPAP behavior was assessed during this 2 week period.
NCT04888182
COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition commencing rehabilitation (7-10-week physical activity program) were randomized to receive a high protein diet (≥ 25 energy percentage) or standard care.
NCT04882410
Background: Acute exacerbation of chronic obstructive pulmonary disease (ae-COPD) has a gold standard treatment: non-invasive ventilation (NIV). However, this treatment sometime fails, and an invasive mechanical ventilation (IMV) is required. The extracorporeal CO₂ removal (ECCO₂R) device can be an alternative to intubation. The aim of the study is to evaluate ECCO₂R efficiency and safety and enlighten ECCO₂R benefit/risk compared to IMV. Methods: Successive ae-COPD patients for whom NIV failed were retrospectively analyzed during two periods: before and after the ECCO₂R device implementation in our ICU in 2015. We considered the before period as standard of care and patients were treated with IMV. The ECCO₂R device was a pump-driven veno-venous system (Xenios AG).
NCT04879030
The investigators hypothesized that the empirical use of fluoroquinolones together with beta-lactam antibiotics will change their therapeutic success in patients with acute exacerbations of COPD compared to that in patients in whom a single beta-lactam treatment was used. The main goal of this study was to compare the clinical and bacterial success from the use of a combination of beta-lactam and fluoroquinolone antibiotics with that of a single beta-lactam treatment, in adult patients with COPD exacerbations.
NCT04739774
The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.
NCT02050022
Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease that is characterized by loss of lung function, leading to breathlessness, poor quality of life, loss in productivity, and increased mortality. The World Health Organization estimates that COPD will be the third leading cause of death worldwide by 2020, accounting for more than 7 million deaths annually. COPD patients frequently experience 'lung attacks', during which breathlessness, coughing, and sputum production dramatically increase, leading to urgent office visits, emergency admissions and hospitalizations. Lung attacks reduce patient quality of life and cost the Canadian health care system nearly $4 billion dollars each year in direct and indirect costs. Lung attacks can be effectively managed if they are identified and treated early, but symptoms of a lung attack often overlap with those of other common conditions such as heart failure, pneumonia and even influenza. Because there are no tests that can separate lung attacks from these conditions, doctors struggle to accurately diagnose lung attacks at an early stage when drugs are most effective. This can lead to a delayed or even incorrect diagnosis and inappropriate treatment. This research will address this critical need. Our goal is to improve COPD patient care by developing new blood tests that will help identify patients who are in the early stages of a lung attack. Doctors will be able to use these tests to treat lung attacks at earlier stages than is currently possible. These blood tests will enable doctors to personalize management of COPD to meet the needs of the individual patient. Hypothesis: New biomarker blood tests can be used to better identify and manage patients with COPD.
NCT04851093
This study aims to objectively evaluate the clinical efficacy and safety of Traditional Chinese Medicine in the treatment of AECOPD Risk Window, providing a basis for the formulation of TCM treatment plan with AECOPD.
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.
NCT02791451
This is an open-label single-center 6-month prospective clinical trial predicting exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the Turku University Hospital due to acute exacerbation of COPD.
NCT04842903
Purpose: The purpose is to determine the effect of therapeutic touch on the sleep quality and anxiety of individuals with chronic obstructive pulmonary disease. Material and methods: This study was conducted between March 2018 and March 2019 as a randomized controlled experimental study conducted with pre-test post-test model. In addition to the routine nursing care, therapeutic touch (TT) and study scales were applied to the experimental group for a total of three sessions, once a day and 10 minutes each, for three consecutive days and only study scales were applied to the control group. The data was collected using Personal Information Form, Richard-Campbell Sleep Questionnaire and State Anxiety Inventory.
NCT03899558
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing symptoms called acute exacerbations (AECOPD). Exacerbations occur more often as the disease progresses and are a leading cause of emergency hospitalisation. Patients recovering from exacerbations are at high risk of deteriorating, with one quarter readmitted to hospital within thirty days. COPD thus imposes immense burdens on the National Health Service and patients. This research will investigate the effects of using humidified nasal high-flow (HNHF) during recovery from severe COPD exacerbations. HNHF delivers warmed, humidified air under flows of up to 60 litres per minute through a nasal interface. This has been shown to improve clinical outcomes, including exacerbation frequency, hospitalisations, breathlessness and quality of life amongst COPD patients with respiratory failure. It is thought to achieve this by improving secretion clearance and providing positive airways pressure which supports the breathing system. Patients admitted to St Thomas' Hospital, London with COPD exacerbations will be recruited. Prior to discharge, participants will be randomised to receive either usual care alone or usual care plus a HNHF device, which they will be trained to use for a regular period daily. Usual care includes inhalers, steroids and may include antibiotics. Participants will be followed up for 30-days after hospital discharge using weekly assessments, daily symptom diaries and wrist-worn watch-like devices that detect physical activity. This will enable evaluation of the clinical effects of HNHF on re-exacerbations, readmissions, breathlessness, physical activity and quality of life. Device usage will also be quantified. Participants who receive devices will be interviewed to explore their experiences. After the 30-day home follow-up period, a sub-group of participants will undergo detailed breathing tests during and after exercise to explore the effects of HNHF on the respiratory system.
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.
NCT03137992
The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).
NCT04146948
The purpose of this study attempts to investigate the differences and relationships of respiratory parameters, muscle activity, and dyspnea during ADL between patients with COPD and age-matched healthy participants.