View clinical trials related to Lung Diseases, Obstructive.
Filter by:The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.
Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.
After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.
This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.
Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease, COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected acute exacerbation of COPD + / - pneumonia. Background: Patients with COPD exacerbation often get antibiotics. There is considerable criticism of this, many of these patients are not bacterially infected and the antibiotics overconsumption can lead to resistance development and side effects. The purpose: To show that one can reduce the consumption of antibiotics among patients hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A sub-objective is a validation study of mini VIDAS ® / Biomérieux equipment to the current gold standard in measuring procalcitonin, Kryptor/ BRAHMS. Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of age and there must be a signed informed consent. Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient´s danish personal identification number, not last digit (gender-fixed) (CPR-number). Even = procalcitonin-guided, Uneven = Control. 2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days after inclusion. Create a biobank in the study consisting of blood à 8 ml up to a maximum of 4 times taken for PCT measurements, the subsequent validation study of MiniVIDAS ®. Biobank destroyed 15 years after the completed project. Statistical considerations: 1. Sample size / Sample Size: A total of 120 patients (please see the basis for this estimate of the Protocol). 2. Analyze: A) Antibiotics stopped on day 5 B) Defined Daily Doses Reads aloud, 1) narrow spectrum, 2) broad spectrum, and 3) a total of the two groups between the (Mann-Whitney U test) C) Hospitalization within 28 days after the first hospitalization the year - the two groups between (Mann-Whitney U test). Doctor Jens-Ulrik Jensen stands for analyzes. Statistics program "SAS v. 9.1.3" is used. Economics: The study funded by the participating departments. Responsibility: The study was conceived and run by doctors in Pulmonary Medicine Department and Department of Clinical Pharmacology, both Bispebjerg Hospital and Department of Clinical Microbiology, Hvidovre Hospital. Science Ethics: There has been a thorough research ethics discussion of the project in the project with emphasis on an assessment of the advantages and disadvantages that might be for the participating patients and society as a whole now and in the future. Conclusions A and B of this discussion is summarized as: A. Advantages and Disadvantages: The treating physician has at any time the opportunity to start / continue antibiotic behandlling for the overall assessment whether PCT value. In addition, in the past, in large studies with a total of> 2000 patients, demonstrated that there are drawbacks to the use of antibiotics depending on a displayed value of PCT in patients hospitalized with acute exacerbations of COPD. Mortality and hospitalization will be monitored in this study. However, there may occur side effects to blood sampling, usually transient ecchymosis blood sampling site. If the strategy results in a reduced consumption of antibiotics, it is expected that the incidence of antibiotic-associated adverse events decreased - this for the benefit of the patient. B. Usefulness for society: Based on the results from this study will be a high degree of certainty to conclude whether this new treatment strategy can provide benefits for future patients in the form of reduced antibiotic consumption, less antibiotic associated adverse events, reduced resistance development / selection among bacteria and overall lower economic costs. Based on these considerations, believes the project, the project can be carried out with respect for the participating subjects to integrity. Quantity: It is expected to be included 120 patients in this scientific study. Database: data (case report forms) stored in archive of Pulmonary Medicine Department for 15 years. Create a database with the information. Personally identifiable data will only be present in the clinical hospital. During the completion of the experiment can provide essential health information about the subject's state of health. This will the subject be informed, unless clearly opted out of this on the consent form. The project reported to the Data Protection Agency. Level: With blood sample (8 mL) on day 1 and then every 2 days in the intervention group (the "active group"), this part of routine blood sampling. At discharge stops blood and the patient should not attend the blood after discharge.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data have shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how typical inpatient COPD care, and how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This grant brings together an outstanding group of researchers who have the necessary clinical, content and methodological expertise to successfully complete this work. These studies will provide invaluable information about inpatient and outpatient management for a disease which has a tremendous impact on healthcare.
Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.
- Evaluate subjects in an prospective observational study - Subjects will be administered scientifically validated questionnaires - Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in: 1. Exercise capability, dyspnea and quality of life as primary endpoints 2. Utilize: 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk test (6MWT) 5. Epworth Sleepiness Scale (ESS) - The secondary endpoints will be: 1. Rate of exacerbations, sleep quality 2. Health care utilization (emergency room encounters, hospital admissions)