Active clinical trials for "Emphysema"

The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

Systemic inflammation is present in chronic obstructive pulmonary disease (COPD), which has been linked to cardiovascular morbidity and mortality. We determined the effects of oral and inhaled corticosteroids on serum markers of inflammation in patients with stable COPD.

Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy. Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exercise physiology and patient-reported outcomes and the impact of the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) on cardiopulmonary function, metabolism and changes in body composition. Study design: This study is a randomized controlled trial with 3 study-arms. Group 1 will first follow a PR program and afterwards undergo the EBV treatment. Group 2 will first undergo the EBV treatment and approximately 8 weeks later will follow a PR program. Group 3 will only undergo the EBV treatment (and can choose to follow a PR program after completing the 6 month FU visit). Study population: The study population exist of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment using one-way valves. Intervention: Most patients will undergo a bronchoscopic lung volume reduction treatment using endobronchial valves and a pulmonary rehabilitation program. One group of patient will under a bronchoscopic lung volume reduction treatment using endobronchial valves and can choose whether they also want to follow a pulmonary rehabilitation program afterwards. Main study parameters: The main study parameter is the difference in change in endurance time measured by an endurance cycle test between the EBV treatment group and the bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).

Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence of peripheral muscle dysfunction, which can have significant clinical consequences, including decreased exercise capacity, reduced quality of life, and even a higher mortality rate. Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with one-way endobronchial valves (EBV) is a minimally invasive intervention which improves exercise capacity and physical activity in patients with severe emphysema. This positive effect is also related to weight gain and alterations in body composition. The physiologic and structural adaptations of skeletal muscle function after EBV treatment has never been investigated before. Objective: To investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in response to EBV treatment. Study design: A single center, prospective clinical trial with a single-arm pretest-posttest design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies before and after placement of EBVs. Study population: Patients with severe emphysema who are scheduled to undergo EBV treatment. Main study parameters/endpoints: The difference in quadriceps phosphocreatine concentration (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during progressive exercise, and recovery rate will be measured by 31P-MRS to assess the physiological effect of EBV treatment on skeletal muscle function and its bioenergetics. Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber type composition, mitochondrial density, master regulators of muscle oxidative programming, and mitochondrial respiration before and after EBV treatment.

Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition . Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty

This is a 6 week crossover study in smokers with and without COPD to evaluate whether 2 weeks of dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) improves pulmonary perfusion (i.e. blood flow in the lungs measured on a contrast CT scan) compared to placebo.

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency.

Aims: To prove the benefits of an specific strength training program in COPD patients compared to those achieved with the traditional endurance training. We will assess which is the proper training modality and which of them is the most beneficial according to the features of the patient to whom it is applied. Subjects and Methods: We will study 66 patients diagnosed of COPD with a moderate-severe obstruction (FEV1<60%) and clinically symptomatic. The monitoring will be done for 3 moths. Patients will be differentiated between COPD with "predominant chronic bronchitis" and COPD with "predominant emphysema", with regard to clinical, functional and radiological criteria. After stratification of the sample, patients will be prospectively assigned to three groups of 22 patients each: a) Endurance training group, on cycle ergometer at a workload of 70% VO2max. b) Strength training group, with 5 different weightlifting exercises (4 sets of 6-8 repetitions). c) Mixed training group, with half the time dedicated to each type of training. Training will be developed during 12 weeks, three times per week, in 40 minutes sessions. Analysed variables, at the beginning and at the end of program will be: Chest X-ray, basic blood analyses, electrocardiogram, simple spirometry and bronchodilator test, blood gases, static pulmonary volumes, diffusion measurement and respiratory muscle pressure. Muscle strength will be assessed by means of 1RM test and the Myometer® dynamometer. Using the muscle skeletal ultrasound, we will control changes in muscle fibre size. Maximal and submaximal exercise tests on cycle ergometer will be also performed, so as a walking test (shuttle walking test). At last, we will assess treatment effect on dyspnea (Mahler's test) and quality of life (CRDQ). Hypothesis: A strength training program would significantly increase peripheral muscle power. This type of training would mainly have effect on the "predominant emphysema" COPD patient, where the important weight lost causes a decrease in muscle strength.

The purpose of this study is to show safety and feasibility to administer patients own mesenchymal stem cells to show signs of repair of emphysematous lung tissue