COPD Exacerbation

The STOP-COPD trial is a randomized, patient-blinded, prehospital clinical trial designed to evaluate the effect of titrated oxygen therapy compared to standard oxygen treatment in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The primary objective is to determine whether a titrated oxygen strategy targeting SpO₂ 88-92% can reduce 30-day mortality compared to the current standard practice using 100% compressed oxygen as a nebulizer driver.

The primary aim is to determine whether nebulized Formoterol twice daily plus Revefenacin once daily is non-inferior to standard-of-care nebulized Albuterol and Ipratropium therapy four times daily in relieving dyspnea among patients with ECOPD presenting to the ED and requiring hospitalization, as measured by the Modified Borg Dyspnea Scale. The hypothesize is that patients in the ED for ECOPD, improvement in symptoms, safety, and length of ED or hospital stay after treatment with nebulized Revefenacin and Formoterol will be non-inferior to the Albuterol and Ipratropium combination. The long-acting bronchodilator regimen will provide comparable symptom control with fewer total drug doses compared with standard treatment with short-acting bronchodilators, namely, nebulized Albuterol and Ipratropium. To the best of our knowledge, this will be the first prospective, randomized, double-blind investigation to compare a combination of long-acting nebulized LAMA/LABA bronchodilators with a standard-of-care combination of short-acting nebulized SAMA/SABA bronchodilators in patients with an ECOPD in the ED/hospital setting.

The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age \>21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and was associated with a significant increase of disability-adjusted life years. In Sweden the prevalence of COPD is approximately 8% bringing the annual total estimated cost for society of 9.1 billion SEK. About 1/3 of patients with COPD undergo periods of acute worsening of respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1 year) and long-term mortality (\> 50% at 5 years) and high risk of re-hospitalization. Because patients with COPD often suffer concomitant disorders that significantly worsen their health status and vital prognosis, the management of the patients is not only the management of COPD but must include identification and treatment of other concomitant chronic diseases. Accurate diagnosis, assessment of severity, and long-term interdisciplinary management of both COPD and concomitant chronic diseases in patients with COPD could be associated with a decreased number of hospitalizations and deaths, improved quality of life and decreased health care utilization in the following 3 years. This longitudinal study will evaluate the effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD and multimorbidity in patients. This is a prospective, open label, cohort study using design of intervention and registries data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years of recruitment period) and 1-year data collection from the National Registries. The study will compare number of rehospitalizations from all causes of patient recruited after a hospitalization due to acute exacerbations of COPD to control patients included from the Swedish Airway Register (SAR). The selection of the control population within the SAR is based on risk score matching. At the first visit a thorough individual's assessment will be performed. The assessment includes information about demographics, COPD and exacerbations, medical history, comorbidities, vital parameters, blood and sputum tests and assessment of quality of life. Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol. The last visit will take place at 5th year after the study start. The "end of study" is defined as last visit of the last subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs will be combined with the data from SAR and complemented with data from Swedish National Registries.

This study aims to develop predictive models for patients with a diagnosis of COPD at discharge of an index admission on these outcomes using machine learning: Primary outcome: Early admission Secondary outcomes: 1. Frequent readmission 2. Composite outcome (Early + Frequent readmissions) 3. Mortality 4. Longstayers

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)

After a COPD exacerbation, many individuals experience severe weakness in the leg muscles, especially the quadriceps. This weakness can make daily activities difficult and slow down recovery. Traditional respiratory rehabilitation usually focuses on endurance training, which is effective but often hard to tolerate soon after an exacerbation due to persistent symptoms and limited functional capacity. This study aims to compare two early rehabilitation approaches during recovery from a COPD exacerbation: a maximal strength training (MST) programme using high loads and few repetitions, and a traditional endurance-based training programme. The investigators aim to determine whether MST is easier to tolerate, especially in terms of breathlessness, and whether MST can improve muscle strength, efficiency, and overall exercise tolerance as well as or better than endurance training. The results will help identify the most suitable rehabilitation strategy for individuals recovering from a COPD exacerbation, particularly for those who struggle with high-intensity endurance exercise.

The goal of this clinical trial is to compare the new asymmetric nasal high flow interface with the conventional high flow nasal cannula in patients with COPD exacerbation. The main questions the study aims to answer are: • Does the use of the asymmetric interface lead to: 1. A greater decrease in the patients' carbon dioxide 2. A greater decrease in respiratory rate and less dyspnea 3. Less need for advanced oxygen therapy measures 4. Same tolerance and comfort 5. Lower heart rate and blood pressure Participants will be asked to: Wear the asymmetric and conventional cannulas for 3 hours each with a 30 minute gap in-between. Arterial blood samples and various clinical parameters will be collected throughout the study period. Researchers will compare the effect of asymmetric versus conventional cannulas to answer the aforementioned questions.

The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients. The main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.

A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only.

The study is a randomized controlled trial. The cases will be divided into two groups as the Homespirometer group and the control group. Breathing exercises, aerobic exercise and peripheral muscle strengthening will be performed in both groups. A home-type spirometer will be given to the homespirometer group and it will be requested to send the spirometric measurement every week. The cases will be called to the hospital for control and evaluated at baseline, 3rd, 6th and 12th months. Evaluations include assessments such as exercise capacity measurement, muscle strength measurement, disease attack frequency, symptom scoring.

Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".

The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are: * Can an exacerbation be detected before the person recognizes they are unwell? * What are the biological signals which provide the best indication of decompensation? * How does this indication of decompensation compare to a daily CAT? Participants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality. Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed. A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.

Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations. Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown. Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT. Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating. Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included. Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care. Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.

Patients admitted in ICU may require invasive mechanical ventilation, using a mechanical ventilator and an endotracheal tube. In ICU, a prolonged duration of invasive mechanical ventilation may be responsible for ventilator-induced lung injury, pulmonary infection, prolonged administration of sedation, neuromyopathy and prolonged length of stay. The goal of the ICU healthcare teams is therefore to reduce the duration of invasive mechanical ventilation as much as possible. ICU patients have many sleep disturbances: sleep fragmentation, sleep stage changes, changes in sleep architecture. These sleep disturbances are due to sedation and analgesia, delirium, patient care activities, noise and altered day-night cycles. Chronic obstructive pulmonary disease (COPD) is a common respiratory disease. COPD complicates the management of invasive mechanical ventilation, particularly weaning of this invasive mechanical ventilation and extubation (removal of the intubation tube). To reduce the risk of reintubation, it is recommended that a weaning test is performed prior to extubation. The purpose of this test is to simulate the conditions of breathing without the help of a ventilator after extubation. If the weaning test is successful, the patient can theoretically be extubated. There are several causes associated with extubation failure, but studies suggest that sleep deprivation or poor sleep quality in the nights before extubation is one of them. In addition, patients with COPD often have chronic sleep disturbances or induced by their stay in the ICU (asthenia, bed rest, anxiety, sedation, etc.). The aim of our study will be to compare the sleep characteristics of COPD patients with a failed weaning test and those with a successful test. Our hypothesis is that patients with a failed weaning test will have more sleep disturbances in the period of 72 hours before the weaning test.

A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.

The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease. The specific aims of the study are: * To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention. * To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation. Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.

The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.

The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation. The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.

The objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of admitted patients in ICU for severe acute exacerbation of COPD, to assess the different therapeutics used, to evaluate the prognosis of patients with short, medium and long term ( 1 year) and the various factors associated with survival in ICU