Active clinical trials for "Pulmonary Disease, Chronic Obstructive"

Chronic obstructive lung disease is a disabling disease that affects people usually after several years of smoke tobacco exposure and affects millions of patients worldwide. The disease is marked by multiples episode of worsening, termed exacerbations necessitating frequent hospitalizations. During these exacerbations, patients present breathless, and in the most severe cases, are admitted to an Intensive Care Unit (ICU) for respiratory assistance. Currently, respiratory assistance is provided by a ventilator via a oronasal mask (referred to non-invasive ventilation, NIV), that helps patients to cope with their breathless. The mask is not always well tolerated and the ventilator sessions are delivered intermittently. In the past decade, a new technique that provides air-oxygen with high flow has been developed. This technique, called High Flow via Nasal Cannula (HFNC) can deliver from 21 to 100% heated and humidified air-oxygen at a high flow of gas via simple nasal cannula. Recent studies have shown that the technique is very efficient to treat patients presenting with acute respiratory failure who don't have any underlying chronic pulmonary disease. Whether the technique would be also efficient in patients with COLD presenting with severe exacerbations has not yet been demonstrated. Since HFNC does not require any mask, it is thought that the comfort of the patient would be much better in comparison to NIV and could potentially help to treat many patients with the disease. The objective of the present study is to study the physiological effect of HFNC as compared to NIV in patients with severe exacerbations of COPD and to show that it is non-inferior to NIV.

Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent airflow limitation and associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. As a major public health problem, COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus, prevention of exacerbations is a important goal in the management of COPD. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint project in 1998. Its goals were to raise awareness of COPD and to improve prevention and treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD patients. However, it is not known whether LABA or LAMA will be more effective for initial relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the secondary endpoints include the frequency of COPD exacerbation, other lung function parameters, CCQ score and mMRC/CAT score.

Rationale: Because long-term use of ICS is associated with an increased likelihood of side-effects such as increased risk of pneumonia and loss of bone density, it is important to limit prescription of ICS to patients who have a clear indication for this treatment. In addition, avoiding unnecessary treatment with ICS could reduce the burden that chronic obstructive pulmonary disease (COPD) puts on healthcare budgets. The recently updated COPD guideline of the Dutch college of General Practitioners (NHG) emphasizes the importance of optimizing medical treatment for COPD patients with only limited room for the use of inhaled corticosteroids. Objective: The objective of the study is to investigate whether discontinuation of inhaled corticosteroids (ICS) for patients without a clear indication for ICS according to current guidelines results in a reduction of ICS use without adverse health effects for the patients involved. Study design: The study is a pragmatic, clustered, parallel group, non-inferiority trial in Dutch general practices with a follow-up of 26 weeks per patient. Study population: 620 COPD patients with confirmed chronic airflow obstruction, aged ≥ 40 yrs who use ICS for at least the prior 6 months without a clear indication. Intervention (if applicable): Guided ICS withdrawal in optimised COPD management. All study participants (of both study arms) will receive recommendations on optimal bronchodilator therapy and a personalized action plan to recognize symptom deterioration in an early stage. Main study parameters/endpoints: Number of exacerbation-free weeks. Secondary study parameters: successful cessation of ICS, time to first exacerbation, number of moderate and severe exacerbations, health-related quality of life, health status, and pneumonias. Moreover, information on the process of care and costs will be collected. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Many COPD patients use ICS without a clear indication. Long-term use of ICS is associated with an increased likelihood of side-effects such as increased risk of pneumonia and loss of bone density and should be avoided in those who do not benefit from it. However, there is a small subgroup of COPD patients that have reduced numbers of exacerbations because of their ICS use and it is impossible to identify a priori the patients who this applies too. Therefore, it is important that the ICS discontinuation is guided to detect potential deteriorations early on.

The Chronic Obstructive Pulmonary Disease (COPD) has shown a progressive increase of morbidity and mortality, suggesting that the lung as a single therapeutic target, has not contributed in the past 20 years, significant changes to the natural evolution of the disease. Direct treatment for systemic changes and comorbidities, in fact, the most responsible for high rates of treatment failure could mean a new hope of life for individuals with COPD. This research project characterized as interdisciplinary and multidisciplinary program will be headquartered in Pulmonary Rehabilitation of the Santa Cruz Hospital which has partnerships with local companies . Its main objective will be to analyze cardiorespiratory and functional capacity in COPD patients not rehabilitated and rehabilitated after the period from 02 to 12 months of treatment in a Pulmonary Rehabilitation program in the municipality of Santa Cruz do Sul - Rio Grande do Sul. Will be included in this survey of COPD patients who were referred to a rehabilitation program with a clinical diagnosis of disease. In research activities to assess cardiorespiratory and functional capacity of COPD, pre and post-program (02 and 12 months) are provided for Pulmonary Rehabilitation. The research subjects will also be subjected to physical exercise protocol as recommended by the GOLD (2009), a period of eight weeks, often 2x / week, where their vital signs are measured before, during and after each session. Thus, it is believed that it will be possible to refine the knowledge of mechanisms by which the judicious use of pulmonary rehabilitation can control the progression of COPD.

Early changes associated with the development of smoking-induced diseases, e.g., COPD and lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells necessary for generation of differentiated airway epithelium. Based on our preliminary observations that epidermal growth factor receptor, known to regulate airway epithelial differentiation, is enriched in BC and its ligand EGF is induced by smoking, we hypothesized that smoking-induced EGF alters the ability of BC to form normally differentiated airway epithelium. To test this, airway BC will be purified using a cell-culture method established in our laboratory and responses to EGF will be analyzed using genome-wide microarrays and an in vitro air-liquid interface model of airway epithelial differentiation.

The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. The objective of this study is to verify if a ground walking program applied to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index" (BODE index). An evaluators-blinded randomized controlled study will be conducted in "Hospital Escola Municipal de São Carlos" where forty patients will be recruited to participate. The volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. It will be evaluated, in the start and at the end of the program, the health related and general quality of life and the Barthel index. Daily, the patient will be submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its BODE index. All patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. All the collected data will be expressed in means and standard deviations or medians and range when appropriated. It will be chosen appropriated tests to compare and correlate them.

The pathomechanisms of COPD are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. Available therapy is in most cases symptomatic. Experimental and clinical observations suggest that treatment with ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional improvement. To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).

Chronic obstructive pulmonary disease is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is that an occupational therapy intervention added to a physiotherapy program and a medical treatment increase the functionality and the quality of life of patients with chronic obstructive pulmonary disease.

The study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.

The critical nature of respiratory diseases, the continuously increasing prevalence of these conditions, and the subjective perception of patients vis-à-vis their pulmonary function and health status underscore the importance of home telemonitoring. These conditions are critical and necessitate close and regular monitoring that may be achieved at distance using telemonitoring. This study will assess a number of measures both at baseline and post-intervention from a number of domains, including Arterial Blood Gases (ABG), BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life, patients satisfaction and utilization of healthcare resources.