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NCT ID: NCT02065921 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort

Start date: September 2006
Phase:
Study type: Observational

1. Background Chronic Obstructive Pulmonary Disease (COPD) is an inflammatory disease of the lungs, which is most commonly caused by smoking. It is characterized as not fully reversible airflow limitation, chronic cough and dyspnoea. Being the fourth leading cause of death worldwide, COPD is an important public health challenge and can be prevented and treated. It is estimated that at least 400,000 individuals in Switzerland are affected by COPD. This number may increase in the coming years due to increasing nicotine consumption. In response to the rising trend, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) has established new guidelines on the global strategy for diagnosis, management and prevention of COPD. Systematic diagnosis and stratification are crucial for effective treatment measures. As COPD is an irreversible and progressive disease, its treatment aims an early detection and better management, which leads preventing progression. Disease management programs have shown that only patients who understand their exacerbation symptoms can benefit. Moreover, it is a major goal to improve health-related quality of life by reducing symptoms and decelerating disease progression. Spirometry is the golden standard for the diagnosis of COPD, to assess the severity of the obstruction, and as a guide for optimal therapeutic measures. 2. Aim of the study The objective of this project is to establish a COPD cohort database to allow high quality research on diagnosis, treatment, complication and progression of COPD on long-term course. Spirometry should be used consistently for the diagnosis and the monitoring of the development of the disease. Using collected information such as spirometric data, disease progression's data and therapeutic measures should help improve the management and self-management of the patients. 3. Methods 3.1 Study design We are conducting a prospective cohort study, based on COPD patients from northern and western Switzerland, who are managed under primary care setting. Patients with mild to very severe COPD (GLOD stages I-IV) are enrolled in the study. Currently, 67 General practitioners (GPs) are participating in our Study. Each GP recruits 1-20 patients with presumed mild to very severe COPD according to criteria of the Global Initiative for Chronic Obstructive Lung disease [GOLD]. Patients' follow-up-visits occurs at 6-month intervals; their history, symptoms and examination status is recorded. Data is entered into an online database either by the physicians or by study team after receiving the collected data questionnaires by facsimile. Data collection includes demographic data, physical examination, spirometric parameters, medical treatment and exacerbation history besides death. A spirometer (EasyOneâ„¢, ndd Medizintechnik AG, Zürich, Switzerland) is used to assess lung function. All participating physicians were instructed on the usage of the spirometer and on how to complete spirometry according to the guidelines. For the assessment of the severity of COPD, we use the spirometric data provided by the GPs. The COPD severity is interpreted according to criteria of the GOLD committee. 3.2 Patient population Patients with newly diagnosed or existing COPD, who are managed in primary-care practices. 3.3 Inclusion criteria - Tiffenau (FEV17FVC) < 70 without reversibility (Increase in FEV1 after inhalation of a bronchodilator <200 ml and <12%). - Age: > 40 years - Both genders - Smokers or ex-smokers of at least 20 pack years. - Informed consent. 3.4 Archiving and Data Retention All study-related records such as medical records, informed consent documents, information regarding participants who discontinued, and other pertinent data will be maintained and therefore retained as long as required by the applicable Swiss regulatory requirements (10 Years). 3.5 Data security The complete data of the study will be entered anonymously into a database. The data is password-protected and can only be accessed by investigators and study members. 4. Publication and authorship 4.1 Publication policy Authorship credit is based on: 1. Substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data. 2. Drafting the article or revising it critically for important intellectual content. 3. Final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

NCT ID: NCT02037828 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Exhaled Breathing Condensate (EBC) Features and Lung Function Decline in Chinese Adults

Start date: June 2014
Phase: N/A
Study type: Observational

Chronic obstructive lung disease (COPD) is a worldwide leading and still increasing cause of chronic morbidity and mortality. The important issue of COPD is its delayed diagnosis. Previous studies have found that accelerated loss of forced expiratory volume in 1 second (FEV1.0) in an individual is considered an indicator of developing COPD. This functional predictive system, due to lower sensitivity, is very difficult to discover high-risk population and earlier stage of the disease. The inflammation occurs earlier than the lung function impairment. Therefore, early detection of the inflammation may theoretically predict the occurrence of COPD and thus may guide early intervention. Proteomics techniques and protein chip techniques provides us high throughput screening method to figure out characteristic inflammatory or metabolic markers of a diseases. It can be used for searching the biomarkers relating to lung function loss. EBC is collected from exhaled gas and is a good non-invasive method for exploring the pathologic process of the airways. Thus we designed this study to identify potential biomarkers associated with rapid lung function decline. This study is divided into two parts: 1) screening potential biomarkers between stable COPD and healthy individuals; 2) verifying significant biomarkers of first part in a community-based nested case-control population for 2 years.

NCT ID: NCT02005094 Recruiting - Clinical trials for To Investigate the Inflammasome Response of Inflammatory and Resting Macrophage

The Role of Inflammasome in Inflammatory Macrophage in Mycobacterium Avium Complex-lung Disease and Mycobacterium Abscessus-lung Disease

Start date: November 2013
Phase: N/A
Study type: Observational

1. To investigate the inflammasome response of inflammatory and resting macrophage derived from healthy human participants by stimulation using MAC or MAB bacilli. 2. To compare the difference of inflammasome response of inflammatory macrophage by MAC/MAB bacilli stimulation between MAC/MAB-LD patients and the colonizers. 3. To study the diagnostic aid from immunological markers in inflammasome response in inflammatory macrophage stimulated by MAC/MAB.

NCT ID: NCT01985750 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Understanding the Importance of Plasticity in the Brain Mechanisms of Dyspnoea Perception

Start date: November 2013
Phase: Early Phase 1
Study type: Interventional

Dyspnoea is the uncomfortable shortness of breath that debilitates millions of patients with lung disease, heart failure and cancer. It is often very difficult to treat. The sensations of dyspnoea are processed in the brain, and we believe that psychological factors modify and amplify these sensations, frequently exacerbating symptoms. This study aims to identify the importance of learning in the brain mechanisms of dyspnoea by investigating a cohort of patients with chronic breathlessness undergoing pulmonary rehabilitation . Pulmonary rehabilitation is a six-week course of exercise, education and group therapy that improves dyspnoea but does not improve lung function. This leads us to hypothesise that some of the beneficial effects of PR maybe due to changes in brain processing, potentially relating to a learning effect. Therefore to probe whether learning is important in the beneficial effects of pulmonary rehabilitation, we intend to modify learning with the drug d-cycloserine. D-cycloserine is an antibiotic that enhances learning due to its effects at N-methyl D-aspartate (NMDA) receptors in the hippocampus. Our previous study in a similar group of patients demonstrated the importance of the hippocampus in breathlessness perception, and we now wish to investigate this in more depth. The study involves collecting physiological, psychological and clinical measures on in conjunction with brain scanning, before, during and once after pulmonary rehabilitation. Subjects will either receive d-cyloserine or placebo before the first four pulmonary rehabilitation sessions.

NCT ID: NCT01961245 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease

Start date: December 2013
Phase: N/A
Study type: Interventional

It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program. A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.

NCT ID: NCT01926275 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

NPPV Added Inspiratory Muscle Training in Severe COPD

Start date: July 2013
Phase: N/A
Study type: Interventional

The aim of this study is to determine whether noninvasive positive pressure ventilation with inspiratory muscle training can improve quality of life and respiratory muscle strength than noninvasive positive pressure ventilation or inspiratory muscle training alone.

NCT ID: NCT01915511 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

IPF/ILD-PRO
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.

NCT ID: NCT01909544 Recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether a localized exercise, in which cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.

NCT ID: NCT01905982 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea, increase activity and have impact on parasympathetic activities.

NCT ID: NCT01858259 Recruiting - Systemic Sclerosis Clinical Trials

Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis

Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis. This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. Aim of this observational try is to identify: - The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression - The potential predictors and confounders for response to therapy