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Lung Diseases clinical trials

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NCT ID: NCT05286918 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Antibiotic Stewardship in AECOPD Through CRP-Guided Management

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Objectives: To determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD health status with usual care. Hypothesis to be tested: (i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups. Design and subjects: Multi-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A&E. Instruments: Clinical COPD Questionnaire and EuroQol-5D Interventions: Both intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP >5mg/dL. Once CRP has declined to <5mg/dL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered. Communication with Receiving Ward Staffs: Participants in the study may transfer to another departments after treatment/ care in A&E. The following communication would be conducted: - A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A&E. The note would also suggest the investigations for the receiving ward staffs. - Telephone handover about intervention group and investigations of the study, and treatments given in A&E to ward. Main outcome measures: The antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation. Data analysis: Intention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation. Expected results: The intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.

NCT ID: NCT05273359 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 2023
Phase: Phase 2
Study type: Interventional

The current literature suggests that the mode of action of benralizumab is to deplete eosinophils through a mechanism of antibody-dependent cell-mediated cytotoxicity. This direct cellular cytotoxicity may not explain all of the benralizumab effects. The investigators propose a set of studies to systematically examine the spectrum of effects of this drug on the immune system.

NCT ID: NCT05250128 Not yet recruiting - Clinical trials for Obstructive Pulmonary Disease

The Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

MICROBOPH
Start date: September 2022
Phase:
Study type: Observational

Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index < 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex. For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed. We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.

NCT ID: NCT05211674 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Analysis of Postural Control of COPD Patients (ATTRACTION)

ATTRACTION
Start date: February 2022
Phase:
Study type: Observational

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. Currently one of the leading causes of death worldwide, COPD is a major socio-economic concern. It is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities). Among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of COPD patients was altered compared to healthy age-matched subjects. This alteration is associated with a greater functional limitation and a higher risk of falling. Although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life. Moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed. The hypotheses of this project are that (1) the postural control of COPD patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised. (2) Several clinical factors are associated with these changes.

NCT ID: NCT05209607 Not yet recruiting - COPD Clinical Trials

Social Media-based Bundle Care of AECOPD Patients.

Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

Chronic obstructive pulmonary disease(COPD) is an incompletely reversible and progressive pulmonary disease characterized by airflow restriction, which is the third leading cause of death worldwide, accounting for 6% of all deaths worldwide. Acute exacerbation (AE) of COPD can accelerate the decline of lung function, worsening pulmonary symptoms, and increase the risk of death in patients. Health education, inhaled technical guidance training, individual self-management, psychological counseling, home oxygen therapy, nutritional support, and other comprehensive interventions can help improve the lung function of COPD patients, alleviate clinical symptoms, improve the quality of life. While a number of COPD applications have been developed, few provide comprehensive assessment and guidance for these kinds of patients. Therefore, the investigators aim to establish a bundle care mode based on the mode of "hospital-home-community-patient", clarify the impact of the management on prognosis, and evaluate the effect of mobile medical-assisted bundle management mode. In this randomized controlled trial(RCT), AECOPD patients will be divided into interventional or control groups randomly. Patients in the interventional group will receive mobile medication and standard of care at the same time (bundle care mode). While patients in the control group will receive standard of care only (traditional management mode). This study will be conducted to compare the effects of traditional and bundle care modes, and to formulate the implementation path and specifications of bundle care for AECOPD patients after discharge in China.

NCT ID: NCT05130294 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Unrefined Salmon Oil as Dietary Supplement in Patient With Chronic Obstructive Pulmonary Disease

Start date: July 2024
Phase: N/A
Study type: Interventional

Research has over decades showed that marine food carries nutritional characteristics that promote human health. As seen in epidemiological studies and based on in vitro and in vivo studies, it is hypothesized that unrefined salmon oil as dietary supplement have anti-inflammatory effect. However, there is sufficient preliminary data to indicate bioactive compounds effect for clinical use, and further clinical trials investigating effect are needed. This trial will investigate the potential anti-inflammatory effect and reduction in the risk of cardio artery disease in patients diagnosed with chronic obstructive disease, COPD.

NCT ID: NCT05120050 Not yet recruiting - Lung Cancer Clinical Trials

Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications

Start date: December 2021
Phase:
Study type: Observational

Prospective comparison of cytology slides (bronchoscopically derived fine needle aspiration samples of lymph nodes at the time of rapid intraprocedural on site evaluation) created with the ASP Health's specimen preparation system to slides made by existing conventional methods.

NCT ID: NCT05114434 Not yet recruiting - Clinical trials for COPD, Chronic Obstructive Pulmonary Disease

Effect of BDP/Formoterol/G on Cough Efficacy in Moderate to Severe COPD Patients (EFFICACE)

EFFICACE
Start date: November 2021
Phase:
Study type: Observational

This prospective, single centre, 8 weeks, open-label study is designed to evaluate in real-life the effect of triple Beclometasone/Formoterol/Glycopyrronium (BDP/F/G) therapy on cough efficacy, assessed by cough peak flow (CPF), after 8 weeks' treatment in patients with moderate to severe COPD. The study's hypothesis is that in symptomatic moderate to severe COPD patients the administration of fixed dose combination BDP/F/G, by reducing lung hyperinflation (LH) and targeting small airways, may accordingly improve the cough efficacy. The increase in cough efficacy might in turn positively influence the quality of life of patients and underlie the prevention of acute exacerbations of COPD.

NCT ID: NCT05087199 Not yet recruiting - COVID-19 Clinical Trials

COVID-19 Infection in Patients With Chronic Pulmonary Diseases.

Start date: November 1, 2021
Phase:
Study type: Observational

This study aims to assess the clinical presentation, radiological patterns and outcome of COVID-19 infection in patients with chronic pulmonary disease. Inter-relationship between the severity of COVID-19 infection and chronic pulmonary diseases.

NCT ID: NCT05067517 Not yet recruiting - Clinical trials for Progressive Fibrosing Interstitial Lung Disease

Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease

Start date: November 2021
Phase: Phase 3
Study type: Interventional

Assess efficacy (as measured by annual rate of decline in FVC) and safety. The hypothesis is that nintedanib will be safe and effective therapy for patients with progressive fibrosing CMD-ILD over a period of 52 weeks. Test Article - Nintedanib 150 mg administered PO twice daily or matching placebo. A total of 160 patients meeting inclusion/exclusion criteria will be randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily. A randomization scheme will be used that balances the group for potential confounders (proportion with PMF or small opacity-only PF-CMD_ILD and proportion of ever- or never-smokers). The dose of the study drug may be reduced to 100 mg twice daily or interrupted temporarily to manage adverse events (AEs).