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Lung Diseases clinical trials

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NCT ID: NCT01952002 Completed - Heart Diseases Clinical Trials

Clinical Safety for the Inspiratory Muscle Training

Start date: October 2012
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. An electrocardiogram will be continuously recorded and the heart rate (HR) and blood pressure (BP) will be evaluated before, during and immediately after a single inspiratory muscle training (IMT) session, consisting of two series of 15 cycles, with one-minute intervals between sets and an initial load of at least 30% of the initial maximal inspiratory pressure (MIP).

NCT ID: NCT01950936 Completed - Clinical trials for Chronic Obstructive Lung Disease

Procalcitonin To Reduce Antibiotics in Chronic Obstructive Lung Disease (ProToCOLD)

ProToCOLD
Start date: November 2012
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT01949727 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Examining Vascular Outcomes in COPD Inpatients (AIM 1) Examining Early Rehabilitation on Discharged COPD Patients (AIM 2)

Start date: October 2013
Phase:
Study type: Observational

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.

NCT ID: NCT01949181 Completed - Lung Cancer Clinical Trials

Blood, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease

Métaux/Poumons
Start date: August 2011
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01948544 Completed - COPD Clinical Trials

Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease

Start date: September 2013
Phase:
Study type: Observational

- 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)

NCT ID: NCT01948518 Completed - Clinical trials for Pulmonary Hypertension

Effect of Sildenafil on Diffusion Capacity in Patients With PH and Parenchymal Lung Disease

Start date: June 2009
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate the acute effects of sildenafil on diffusion capacity, a commonly performed pulmonary function test, which is used to assess the lungs' gas exchange capability. This study does not assess safety or efficacy of the drug. The study does not have clinical end points. The variables studied are diffusion capacity and 6 minute walk after a single dose of sildenafil. This study has been completed.

NCT ID: NCT01947218 Completed - Clinical trials for CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Start date: June 30, 2014
Phase: N/A
Study type: Interventional

Asthma and COPD are characterized by an accelerated decline in lung function associated with incompletely reversible airflow obstruction. This could be the result of lung structural changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the "remodeling" is characterized by mucus cells hyperplasia, overproduction of mucus, and physicochemical, biological and immunological changes. Clinically, this mucus overproduction is reported by patients as the clinical symptom called "chronic bronchitis". Generally, it develops at a bronchiolar level where it is responsible for the progression of these diseases. There is a paradox, because the intrinsic properties of mucus seem rather beneficial so fighting against it may not be really wise at long-term. Especially its defensive effect against microbial agents which remains poorly explained. Currently, no treatment aims to reduce the production of mucus and mechanisms leading to such an overproduction are poorly understood in severe asthma and COPD. The identification of new targets to treat this overproduction of mucus in COPD is therefore of major interest. In view of current knowledge, inflammatory mediators and signal transduction leading to increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2

NCT ID: NCT01946620 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD

Start date: October 2013
Phase: Phase 3
Study type: Interventional

Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.

NCT ID: NCT01945398 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

IMT in Ventilatory Muscle Metaboreflex in COPD

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

This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory muscle metaboreflex through the decrease of calf vascular resistance and increase of calf blood flow in Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01944072 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes

Start date: September 2009
Phase: N/A
Study type: Interventional

Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. Patient's allocation sequence was computer-generated, with consignment in a safe deposit box.