Active clinical trials for "Pulmonary Disease, Chronic Obstructive"

The aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. In this study, the effect of disease severity and respiratory problems on peripheral muscle metabolism of patients with COPD will be explained.

The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to chronic obstructive pulmonary disease.

The aim of the CHOROS ORION study is to describe patients' clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness, clinical and self-reported measures assessed pre- and post-treatment initiation, up to one year of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment. This will allow to assess the short-term impact of treatment, thus contributing to fill the gap of knowledge from the current available medical literature. Moreover, in order to provide also a broader view, patients will be followed up to 52 weeks, where possible. The study results will be interpreted in the context of an observational study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.

Patients with Chronic obstructive pulmonary disease (COPD) experience gradually deteriorating lung function, which may be complicated by acute exacerbations. N- acetylcysteine (NAC) is frequently used in patients with COPD as a mucolytic. Besides its mucolytic effects, high-dose NAC has additional benefits in patients with stable COPD, including improving lung function and reducing exacerbations. Studies on the dose-dependent effects of NAC in COPD patients showed a high dose of NAC was needed to achieve its antioxidant effects and clinical benefits in COPD patients, whereas a dose of 600 mg once daily was not able to increase glutathione levels. According to a study conducted in Hong Kong on patients with stable COPD, 1 year of treatment with high-dose NAC at 600 mg twice daily improved small airways function in terms of forced expiratory flow and forced oscillation technique, and also significantly reduced exacerbation frequency with a decreasing trend in admission rate. In a meta-analysis, patients treated with NAC had significantly and consistently fewer exacerbations of COPD. The role of NAC was examined in a Delphi consensus study involving 53 COPD experts from 12 countries. Respondents agreed that regular treatment with mucolytic agents could effectively decrease the frequency of exacerbations and the duration of mild-to-moderate exacerbations, while delaying the time to first exacerbation and increasing symptom-free time in COPD patients. The panel also approved the doses of NAC with favourable side effect profiles to be recommended for regular use in patients with a bronchitic phenotype. However, there have been conflicting results regarding the efficacy of NAC for treating acute exacerbation of COPD. NAC has not been included as an adjunct for the treatment of COPD exacerbation in international guidelines. As NAC is relatively low cost, readily available, and has a favourable side effect profile as a treatment for COPD exacerbation, it is important to properly assess the clinical benefits of NAC as an adjunct to standard medical treatments to hasten recovery. This study is a double-blind randomised controlled trial on NAC as an adjunctive treatment for acute COPD exacerbation. It will assess the role of NAC in the treatment of acute COPD exacerbation.

The goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on: Relief of dyspnea sensation Length of hospital stay Participants will be receiving the standard therapy of COPD exacerbation plus either inhaled furosemide or inhaled saline over 3 days. They will be asked to: Perform spirometry Fill in dyspnea score Do arterial blood gases (ABGs)

Chronic obstructive pulmonary disease (COPD) is a debilitating and progressive respiratory condition characterized by irreversible airflow limitation. The overall 5-year survival for COPD patients is 56-92%, depending on disease severity. Considering the recent introduction of the Budesonide, Glycopyrronium bromide and Formoterol fumarate Metered-Dose Inhaler (BGF MDI) in COPD therapeutic arsenal as well as the increasingly important role of real-world (RW) data in health care decisions, as it bridges gaps not addressed by randomized clinical trials, there is a need for RW evidence studies that can serve as inputs for Health Technology Assessment (HTA) submissions. In view of this need, this study is designed to generate RW evidence on the clinical and patient-reported outcomes of treatment with BGF MDI over a 52-week treatment period in routine care settings in Greece as well as to shed light on the reasons for switching from dual to triple therapy with BGF MDI, aiming at further characterizing the multifactorial aspects of inadequate COPD management that lead physicians to step-up treatment. The study is mainly descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis. This is a single-country, non-interventional, multicenter, 52-week prospective cohort study, mainly based on primary data collection, which will include adult patients with moderate to severe COPD newly prescribed maintenance treatment with BGF MDI in routine care settings of Greece. This study design has been selected on the basis that such studies essentially, through collecting data generated in the course of routine clinical care about management practices and their outcomes from both the physician and patient perspective, help to bridge the knowledge gap between clinical research in controlled randomized settings and daily clinical practice. In line with the purely observational and non-interventional nature of the study, no changes to the current standard of care will be required and all aspects of treatment and clinical management of patients will be in accordance with local clinical practice and at the discretion of the participating physicians. The conduct of this study will adhere to the applicable national regulatory requirements governing the conduct of such type of clinical research. In addition, the study has been designed and will be conducted and reported in accordance with the ethical principles laid down in the Declaration of Helsinki, the Guidelines for Good Pharmacoepidemiology Practice (GPP) of the International Society for Pharmacoepidemiology, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines where applicable, the European Union (EU) General Data Protection Regulation (GDPR), and the local rules and regulations. Patients will have been prescribed BGF MDI (Trixeo Aerosphere™) prior to informed consent (IC) obtainment and will be treated according to the local prescribing information (Summary of Product Characteristics [SmPC]) of the study medication and routine medical practice in terms of visit frequency and type of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of BGF MDI is clearly separated from the physician's decision to include the patient in the current study. In addition, every medical decision including the course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation according to the product's SmPC. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 12, 24, 36, and 52-week data collection timepoints post-index (i.e., after BGF MDI treatment initiation) with an allowable time window of ±2 weeks for each data collection timepoint. Data collection at the aforementioned timepoints will be performed in the context of on-site routine visits at the private practices/hospital clinics. In addition, a telephone contact will take place at 4 (±1) weeks post-index for the sole purpose of administering COPD Assessment Test (CAT) by phone interview with the patient. Any visits/contacts occurring at other times not pre-planned in the context of the study will not be captured for the purposes of this study, except for safety-related information, exacerbation data, information on BGF MDI and concomitant COPD-related treatments, that will be collected on a continuous basis. Data collection at all indicated timepoints will be performed in the context of on-site routine visits at the private practices/hospital clinics. There are no dose regimens or diagnostic procedures pre-defined within this study plan. Participation in this observational, real-life study and its documentation procedure will not affect the routine treatment situation in any way.

Severe asthma is now widely accepted to be a heterogeneous syndrome consisting of multiple phenotypes identified by specific biomarkers and targeted by tailored biological therapies. However, much remains unclear regarding the best approaches to manage these patients, or concerning the pathophysiological mechanisms underlying the disease. Small airway (SA) are defined as those airways with an internal diameter <2 mm. In patients affected by asthma, it has been reported that SA are the predominant site of airflow resistance. Peripheral airways are thickened in asthma due to chronic inflammation in the epithelium, submucosa and muscle area. It has been suggested that the outer wall is more inflamed than the inner wall, with a higher number of lymphocytes, eosinophils, and neutrophils associated to an increased expression of interleukin-4 (IL-4), interleukin-5 (IL-5) and eotaxin. Moreover, it is well documented that SA inflammation and dysfunction contribute significantly to the clinical impact of asthma and that 50-60% of asthmatics have a SA involvement across all disease severities. An important question is whether SA disease in asthma is variable among distinct asthma phenotypes and whether it occurs in all patients. Cluster analyses have been recently used to identify specific asthma phenotypes, but markers of SA function have not been investigated. However, evidence is accumulating to support that SA dysfunction and inflammation may contribute to distinct asthma phenotypes. Recent findings indicate that SA are significantly affected in severe asthma and that their involvement is associated with worse disease outcomes. It has been reported that patients with asthma and a history of frequent exacerbations per year had a significant SA involvement. Furthermore, peripheral airways significantly contribute not only to the level of asthma control, but also to patients' quality of life and perception of symptoms. At last more thickened SA and higher numbers of eosinophils are detectable in subjects with fatal asthma. The assessment of SA represents a big challenge and requires qualified expertise and sophisticated techniques including body plethysmography, single and multiple breath nitrogen washout, impulse oscillometry (IOS), fraction exhaled NO at multiflow, sputum induction and high-resolution chest CT (HRCT). Such procedures can either provide functional information on the degree/extent of ventilation heterogeneity and air trapping or facilitate the understanding of the inflammatory and remodeling processes. In addition, a number of clinical trials have in recent years demonstrated the efficacy of biologics in severe asthma. Omalizumab, a humanized anti-Imunoglobulin E monoclonal antibody (mAb) has been well recognized as an important option for treating allergic asthma as an add- on therapy for uncontrolled disease. Three anti-IL-5 therapies are currently available for the treatment of severe asthma, including Mepolizumab, Reslizumab, and Benralizumab. The newest biologic agent to be approved is Dupilumab that is a human mAb that targets the subunit of the IL-4 receptor. Biologics represent an innovative strategy for the treatment of severe asthma. In most patients with SAD these drugs control inflammation, improve lung function, ameliorate clinical symptoms, reduce exacerbations and have a marked steroid-sparing effect. However, there is still a significant proportion of non-responders and a lack of validated predictive biomarkers in such subpopulation. In regard to this, very limited findings are available about the effect of biologics therapy on SA.

ERASE PH-COPD is a randomized double-blind study, with 2 parallel groups. Patients with severe pulmonary hypertension due to chronic obstructive pulmonary disease, will be randomly assigned to receive Tadalafil orally or placebo.

The investigators will study whether the drug tadalafil improves shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the Veteran nor the investigator will know whether the Veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.

Evaluate the effect of the use of elastic tape in chest wall and abdomen in the physical capacity, psychosocial distress levels, quality of life and anxiety, and depression symptoms of individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation.