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Chronic Obstructive Pulmonary Disease clinical trials

View clinical trials related to Chronic Obstructive Pulmonary Disease.

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NCT ID: NCT06265623 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).

PROSA
Start date: March 1, 2024
Phase:
Study type: Observational

This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years.

NCT ID: NCT06259188 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effectiveness of Personalized Breathing Exercise Device in Patients With COPD

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

The current "Global Initiative for Chronic Obstructive Lung Diseases" (GOLD) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (COPD) patients from Stage II onwards. Respiratory muscle training applied to individuals with COPD is an important part of pulmonary rehabilitation due to its benefits such as improving pulmonary function and respiratory muscle strength, reducing the severity of dyspnea, and increasing exercise capacity and quality of life. Although there is sufficient evidence in the literature about the benefits of IMT in individuals with COPD. There is little evidence showing the effects of EMT. Studies show that isolated IMT and EMT are effective in increasing respiratory muscle strength, endurance and exercise capacity. Results from a limited number of studies show that combined training of IMT and EMT is superior compared to isolated IMT or isolated EMT in improving exercise capacity and dyspnea. Incentive spirometers, with their different mechanical properties, are low-cost respiratory exercise devices that are widely used in the early postoperative period, lung diseases, long-term bed rest and in situations where it is necessary to maintain or increase the ventilation ability of the lung, but they do not apply any resistance to the respiratory muscles. In the pulmonary rehabilitation guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the necessity of using devices that apply resistance to the respiratory muscles to strengthen the respiratory muscles is underlined. The personalized respiratory exercise device will be a device that has the clinical features of an incentive spirometer and respiratory muscle training devices (inspiratory and expiratory) and can be personalized according to the desired purpose. With the same device, patients will be able to both improve lung ventilation, such as an incentive spirometer, and strengthen their respiratory muscles.

NCT ID: NCT06257667 Not yet recruiting - COPD Clinical Trials

Treatment of Acute Hypercapnic Respiratory Failure With OptiflowTM or Optiflow+DuetTM Nasal Cannula in COPD-patients

DUACT
Start date: March 31, 2024
Phase: N/A
Study type: Interventional

Hypothesis Treatment with HFNC and OptiflowTM+Duet can significantly reduce PaCO2 and normalize pH in patients with COPD exacerbation and acute hypercapnic failure, compared to HFNC with OptiflowTM. Treatment with High flow and OptiflowTM+Duet in patients with COPD exacerbation and acute hypercapnic failure is well tolerated. Aims To investigate the effect of HFNC in combination with either OptiflowTM or OptiflowTM+Duet nasal cannula on PaCO2 levels and pH in patients with COPD exacerbation and acute hypercapnic failure and compare the results of treatment with the two different nasal cannulas. To describe adherence to treatment with high flow and either OptiflowTM or OptiflowTM+Duet nasal cannula. Methods Study design The study will be carried out as a prospective, multicenter, randomized controlled trial. - Patients COPD and acute hypercapnic who do not tolerate NIV-treatment will be treated with HFNC for respiratory support. Patients will be randomized to either OptiflowTM /OptiflowTM+Duet nasal cannulas ("Fisher & Paykel Healthcare", Auckland, New Zealand) - HFNC treatment with allocated nasal cannula, flow 40-60 (prescribed by the responsible clinician) will be initiated, titration of FiO2 till target SO2 is reached (as prescribed by the responsible clinician or by default 88-92%). Maximal flow and target saturation should be reached within 1.5 hours of initiation. - Arterial puncture (registering pH, PaO2, PaCO2, HCO3, SaO2 and Base Excess) will be drawn at baseline and repeated after two hours (±30 minutes and after flow and FiO2 have been stable for 30 minutes) and at termination of the HFNC. - Patients will remain in study till it is decided by the treating physician to terminate HFNC-treatment. Patients who are candidates for invasive ventilations will be excluded from the study if the arterial blood gasses further deteriorate after initiation of HFNC.

NCT ID: NCT06246370 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

An Investigation of the Cervical Region Biomechanics in Patients With Chronic Obstructive Pulmonary Disease

Start date: February 20, 2024
Phase:
Study type: Observational

The aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects.

NCT ID: NCT06234345 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)

TRIPLAR
Start date: February 28, 2026
Phase: Phase 3
Study type: Interventional

Several studies have demonstrated the benefits of the LAMA (Long-Acting Muscarinic Antagonists) + LABA (Long-Acting Beta-Agonists) + IC (inhaled corticosteroids) combination in the treatment of chronic obstructive pulmonary disease (COPD). The use of the triple combination in patients with severe airflow obstruction and a history of flares has been associated with improved lung function, improved patient-reported endpoints and prevention of flares, when compared to LABA, LABA + LAMA and LABA + IC. Furthermore, when compared to dual therapies LABA + IC and LABA + LAMA, triple therapy has been able to reduce all-cause deaths among chronic obstructive pulmonary disease (COPD) patients. Previously published studies have demonstrated that the triple combination of Fluticasone 250 mcg/Formoterol 12 mcg/Glycopyrronium 12.5 mcg was able to improve lung function in chronic obstructive pulmonary disease (COPD) patients with a history of flares. There was also a significant improvement in the mMRC (modified-Medical Research Council) which began in the 2nd week of treatment and continued up to week 12. The association was considered safe and well tolerated, with only mild to moderate adverse events recorded in approximately 25% of the subjects treated in the study. Furthermore, bioavailability studies performed with the components of the combination proposed as experimental drug - Fluticasone/Formoterol/Glycopyrronium - indicated that there is no pharmacokinetic interaction between the 3 active ingredients when they were administered concomitantly to healthy individuals under fasting conditions.

NCT ID: NCT06229509 Not yet recruiting - Dyspnea Clinical Trials

Study of the Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition

CYTODINE
Start date: February 2024
Phase: N/A
Study type: Interventional

Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality. COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority. In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea. Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance. The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.

NCT ID: NCT06212765 Not yet recruiting - Malnutrition Clinical Trials

Oral Citrulline Supplementation in COPD Patients With Malnutrition

CITRUS
Start date: January 25, 2024
Phase: Phase 3
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown. The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI < 20 kg/m2 if < 70 years old or < 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.

NCT ID: NCT06174207 Not yet recruiting - Asthma Clinical Trials

Hyperoxia During Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation. Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air. Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged >18 years; stable condition >3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham air will be the primary outcome of this study. Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of <0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.

NCT ID: NCT06170125 Not yet recruiting - COPD Clinical Trials

QualiTy of Life Evaluation in Patients With ChRonic ObstructIve Pulmonary Disease Who Require Tiotropium as additiOnal treatmeNt.

TRITON
Start date: March 2024
Phase:
Study type: Observational

Chronic obstructive pulmonary disease (COPD) is a complex, heterogeneous disease usually with a decline lung function and worsening symptoms; hence, both forced expiratory volume in 1 s (FEV1; lung function) and validated patient-reported outcomes (PROs) are used in clinical trials to assess disease severity and response to treatment. The PROs are different in terms of their scope of assessment and in the information that they capture. PRO questionnaires such as the Baseline Dyspnoea Index (BDI), Transition Dyspnoea Index (TDI) and modified Medical Research Council (mMRC) dyspnoea scale are used to assess dyspnoea, whereas the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT) and St George's Respiratory Questionnaire (SGRQ) are commonly used to assess patients' health status . Furthermore, the mMRC scale is unidirectional and minimally responsive to treatment interventions, while the BDI, TDI, CAT, CCQ and SGRQ (approved by the USA Food and Drug Administration) are multidirectional.

NCT ID: NCT06147674 Not yet recruiting - Stroke Clinical Trials

Evaluation of VQm PHM on Pulmonary Health Parameters for ICU

Start date: January 15, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM™ to existing clinical measurements. The main questions it aims to answer are: - Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements. - Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the VQm PHM™ when compared to available reference measurements.