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NCT01285180
Daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (PDE-4) for patients with severe chronic obstructive pulmonary disease (COPD) experiencing chronic cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment. With its mode of action Daxas can reduce exacerbations rates and improve lung function parameters which may result in a better health-related quality of life and an improved long-term management of COPD. The aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting. Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, socio-demographic data and cost-of-illness data will be recorded. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas.
NCT01009424
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.
NCT00242294
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
NCT02698007
Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years. Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough. Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide. Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation. Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients. Or benefits and safety LMA in front of intubation during bronchoscopy. Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy . Another objective, to examine whether there is a special group of patients enjoy the LMA more than others. Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control. Study group : LMA is inserted under sedation and used during the procedure. Control group - performing bronchoscopy under sedation without LMA. About 50 people are needed each group.
NCT02363920
Nasal High Oxygen Flow (HOF) has been demonstrated to reduce the re-intubation rate in hypoxic patients and ameliorate breathing pattern in hypercapnic patients. The aim of this study is to better understand the physiological mechanism underlying these results, assessing the respiratory mechanics in stable hypercapnic COPD patients.
NCT00446667
COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.
NCT02413359
The patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.
NCT02706600
There are currently 900,000 people in the UK with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), The disease is progressive and often causes disabling symptoms such as chronic cough, breathlessness and reduced tolerance to exercise. National Institute for Health and Care Excellence (NICE) recommends that patients with COPD have a self management plan (SMP). The utilisation of SMP's has been shown to reduce healthcare utilisation, improve quality of life, and reduces the need for hospitalisation. Currently SMP's are delivered to patient in a paper format, myCOPD is a web based self management system which has been developed by Healthcare professional and patients encompasses the principles of Self management and offers a viable solution to a national recommendation. The study will compare paper self management plans against the online version myCOPD. The study aims to recruit 60 patients with a diagnosis of COPD during their admission to hospital for an exacerbation or flare up of their COPD. Patients will be given an information sheet during their admission and prior to leaving hospital be asked if they wish to participate in the study. Patients will participate in the study for no less than two months and a maximum of three months. 30 patients will receive written self management and 30 will receive online self management. There will be a total of 4 visits for the duration of the study. The screening visits will comprise of written or verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires, inhaler technique assessment and delivery of either a written self management plan. The telephone visits will comprise of verbal consent and completion of the COPD Assessment Test. The End of Study visit will comprise of verbal consent, Demographics, Medical, exacerbation and healthcare utilisation history, Quality of Life questionnaires and assessment of inhaler technique.
NCT00856193
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
NCT02881385
Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between humans and ventilators,making people uncomfortable and prolonging weaning time.Some ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it will make the transforming more synchrony with humans.Our prospective observational study will prove the superiority of the auto cycle function.
NCT02542254
This study evaluates the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a randomised sequence: 1. salbutamol, 2. ipratropium, 3. salbutamol + RPL554, 4. ipratropium + RPL554, 5. RPL554 6. Placebo
NCT01976130
Study hypothesis: Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways
NCT01976117
Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection
NCT02888886
The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD). Secondary purposes are: 1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD, 2. To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD, 3. To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased, 4. To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.
NCT02875522
The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease. Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD. The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.
NCT02873988
Airway epithelium integrity is essential to maintain its role of mechanical and functional barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial repair may participate in airway remodelling. The objective was to determine if airway epithelial wound repair of airway epithelium is abnormal in COPD.
NCT01601977
COPD continues to be a cause of major morbidity for patients. Those patients who also have respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and death and have worse health related quality of life than similar COPD patients without respiratory failure. Treatment options in this group of patients have been limited and data to support the use of machines to assist breathing (non-invasive ventilators) in stable patients are limited. A major limitation of these devices has been patient acceptance and achieving sufficient control of sleep breathing disturbance. Currently devices are set at a fixed pressure to support the breathing throughout the night. The new software within the trial device will aim to better match the support provided by the machine to that needed by the patient. It is hoped that this may offer enhanced comfort as well as superior control of respiratory failure.
NCT00633776
The purpose of this study is to compare the effects of nebulized formoterol fumarate (Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15 minutes. Foradil is taken in a single quick, deep inhalation.
NCT02466347
The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal block.
NCT00361426
Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the above parameters.
