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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT04008615 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease

PH-6MST
Start date: August 1, 2019
Phase:
Study type: Observational

Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment. Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation. In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription. The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation. The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored. Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed. Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise. Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer. The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.

NCT ID: NCT04008017 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Eosinophilic Cationic Protein as a Biomarker in Diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Start date: August 1, 2019
Phase:
Study type: Observational

Chronic obstructive pulmonary disease is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. It is changed to acute exacerbation of Chronic obstructive pulmonary disease when respiratory symptoms worsen, beyond normal day-to-day variations, severely enough that changes in medication are required. Inflammation is a core feature of acute exacerbation of Chronic obstructive pulmonary disease since it gives insight into the pathological changes causing an exacerbation. Eosinophils may play a significant role in airway inflammation in some patients with Chronic obstructive pulmonary disease. Previous studies have indicated that eosinophilic airway inflammation is also associated with the development of severe acute exacerbation of Chronic obstructive pulmonary disease. Eosinophilic Cationic Protein has various biological activities, including antibacterial, antiviral, antiparasitic and neurotoxic functions, and it contributes to the regulation of fibroblast activity. Eosinophilic Cationic Protein also induces airway mucus secretion and interacts with the coagulation and complement systems. Eosinophilic Cationic Protein has been developed as a marker for eosinophilic disease and quantified in biological fluids including serum, bronchoalveolar lavage and nasal secretions. It is found in diseases such as allergic asthma and allergic rhinitis but also occasionally in other diseases. Only activated eosinophil granulocytes release the granule content and therefore the determination of Eosinophilic Cationic Protein concentration is a considerably more specific indicator of eosinophil inflammation than eosinophil granulocyte count in peripheral blood as serum Eosinophilic Cationic Protein levels increase during acute exacerbation of Chronic obstructive pulmonary disease

NCT ID: NCT04004689 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease

6STaR-2
Start date: August 1, 2019
Phase:
Study type: Observational

Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment. Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include cardiopulmonary exercise testing to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation. In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription. The 6-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation. The aim of this study was to develop and validate a prediction equation to set rehabilitation intensity for patients with severe to very severe chronicle obstructive pulmonary disease attending pulmonary rehabilitation, with the use of a simple, readily available field test. Therefore the investigators sought to determine, if it exists, a relationship between the plateau heart rate from the first and last 3 minutes of the 6-minute stepper test and the heart rate from the first ventilatory threshold from the cardiopulmonary exercise testing in order to individualize pulmonary rehabilitation in patients with severe to very severe chronicle obstructive pulmonary disease.

NCT ID: NCT04000958 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

PIFR-based Inhalation Therapy in Patients Recovering From AECOPD

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study is designed to determine whether the optimized inhalation therapy based on peak inspiratory flow rates (PIFR) measured against the simulated resistance can reduce the rate of treatment failure in patients recovering from acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Errors in inhaler use and quality of life are also to be evaluated. The study will recruit 460 patients with AECOPD whose exacerbated symptoms are relieved by 5-7 days of standard therapy. The participants are divided into PIFR group and control group in a 1:1 ratio according to a random number table method. All the patients will be given inhaled corticosteroid(ICS)/long-acting β agonist(LABA) (budesonide/ formoterolSymbicort turbuhaler® 160/4.5 μg bid or Beclometasone/ Formoterol Foster® pressure metered dose inhaler(pMDI) 100/6 μg 2 puff bid). For symptomatic patients before acute exacerbation, Spiriva handihaler® 18μg qd or Spiriva respimat® 2.5μg qd will be prescribed in combination with ICS/LABA. For PIFR group, PIFR is measured by InCheck DIAL(Clement Clarke International Ltd, Harlow, UK and Alliance Tech Medical). If PIFR is less than 60L/min , the patient will be given pMDI with spacer. If PIFR value is over 60 L/min, the patient will be given dry powder inhaler(DPI).). The control group will be given DPI or pMDI with spacer according to the judgment of a respiratory physician. Both groups will be taught to use the device after the prescription, and then be reminded to use medication via a WeChat public account. The primary endpoint of the study is the 30-day treatment failure including AECOPD recurrence resulting in an emergency visit, admission, or need for intensified medication). The secondary endpoints of the study are the error rate of inhalation device use, satisfaction with inhalation devices, symptoms and quality of life, 30-day mortality, chronic obstructive pulmonary diseases(COPD)-related treatment costs and PIFR.

NCT ID: NCT03990155 Recruiting - Clinical trials for Respiratory Failure With Hypercapnia

Extra-Corporeal Carbon Dioxide Removal in Exacerbations of Chronic Obstructive Pulmonary Disease

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Around 20% of the patients requiring hospitalization for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) develop hypercapnia, which is associated with an increased risk of death. Once Non Invasive Ventilation (NIV) has been initiated, a reduction in Respiratory Rate (RR) and improvement in pH within 4 h predicts NIV success. If pH <7.25 and RR >35 breath per minutes persist, NIV failure is likely. Worsening acidosis, after initial improvement with NIV, is also associated with a worse prognosis. In addition, it has been shown that delaying intubation in patients at high risk for NIV failure has a negative impact on patient survival. Hence, assessing the risk of NIV failure is extremely important. NIV has some limitations: a) intolerance, discomfort and claustrophobia requiring frequent interruptions; b) poor patient-ventilator synchrony, especially in presence of air leaks or high ventilatory requirements. Since removing carbon dioxide by means of an artificial lung reduces the minute ventilation required to maintain an acceptable arterial partial pressure of carbon dioxide (PaCO2), the investigators hypothesize that applying Extra-Corporeal CO2 Removal (ECCO2R) in high-risk AECOPD patients may reduce the incidence of NIV failure and improve patient-ventilator interaction. After the beginning of ECCO2R, NIV could be gradually replaced by High Flow Nasal Cannula Oxygen Therapy (HFNCOT), potentially reducing the risk of ventilator induced lung injury, improving patient's comfort and probably allowing the adoption of a more physiologically "noisy" pattern of spontaneous breathing.

NCT ID: NCT03989271 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Biological Effects of Quercetin in COPD

Start date: October 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary disease. It is small study with 8 subjects receive quercetin 2000 mg/day and 4 subjects receive placebo.

NCT ID: NCT03988322 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Computed Tomography Screening for Early Lung Cancer, COPD and Cardiovascular Disease in Shanghai, China

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Low-dose chest computed tomography (CT) is considered as a screening method for early detection of lung cancer in the population at risk, and it also allows to detect chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD). Studies in European population showed the benefit of volumetric assessment of CT screening-detected lung nodules compared to diameter-based assessment. Screening for COPD and CVD, in addition to lung cancer, may significantly increase the benefits of low-dose CT lung cancer screening. The objective is to assess the screening performance of volume-based management of CT-detected lung nodule in comparison to diameter-based management, and to improve the effectiveness of CT screening for COPD and CVD, in addition to lung cancer, based on quantitative measurement of CT imaging biomarkers in a Chinese screening setting. Thus, a population-based comparative study will be performed in Shanghai, China.

NCT ID: NCT03987633 Recruiting - Obesity Clinical Trials

EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality

Start date: February 1, 2021
Phase:
Study type: Observational

Health inequality and genetic disparity are a significant issue in the United Kingdom (UK). This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations. The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations. This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK. The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.

NCT ID: NCT03945968 Recruiting - Stroke Clinical Trials

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.

STOPRISK
Start date: July 1, 2019
Phase:
Study type: Observational

Study is conducted to assess the prevalence and structure of comorbidity among patients undergoing abdominal surgery and produce the stratification of the risk of postoperative complications by identifying independent predictors for its development.

NCT ID: NCT03942302 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Characterization of Variable MARrcha's Diary Variables as a Useful Measure

Start date: March 1, 2019
Phase:
Study type: Observational [Patient Registry]

Validate a simple clinical tool to evaluate physical activity (the question "How many minutes does it walk per day?" Or equivalent), compared to the rest of the collected physical activity data (PROactive questionnaire and objective physical activity data by means of an accelerometer record) in patients with COPD.