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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT06105814 Not yet recruiting - Pneumonia Clinical Trials

Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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

Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD. COPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.

NCT ID: NCT06101459 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups. The main questions it aims to answer are: - Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker? - Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker? - Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker - Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?

NCT ID: NCT06085261 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

COPD: A Multi-center Supervised Tele-rehabilitation Study

COPDMUST
Start date: November 2023
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.

NCT ID: NCT06061679 Not yet recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection

Impact of Switching COPD Patients From Inhaler Devices to the Omron C28P Nebuliser.

OMRON
Start date: November 2023
Phase: N/A
Study type: Interventional

The cornerstone of COPD therapy is based on the use of inhalation drugs. The correct use of devices is crucial; a suboptimal use technique is the cause of a possible clinical deterioration with a consequent increase in exacerbations and healthcare expenditure. Inhalation of drugs by nebulizer, in specific populations of patients who have shown poor adherence to inhalation therapy and poor symptomatological control, could be a more advantageous therapeutic strategy than pMDIs or DPIs, not requiring coordination at the time of delivery and not requiring an effective inspiratory effort. The objective of this study is to evaluate the effects of the transition from portable inhalers (pMDIs or DPIs) to an innovative prototype Omron C28P nebulizer, measured primarily as changes in treatment adhesion and respiratory symptoms. The sudy design is open, single-arm, real-life, prospective study conducted in two tertiary level respiratory centers in Italy, with assessments conducted on the occasion of patients' visits to their doctor.

NCT ID: NCT06028711 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Education Impact on Rehabilitation of Hospitalized Patients With Chronic Obstructive Pulmonary Disease.

Start date: September 2023
Phase: N/A
Study type: Interventional

The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to chronic obstructive pulmonary disease.

NCT ID: NCT06026709 Not yet recruiting - Depression Clinical Trials

Effectiveness and Cost-effectiveness of Digital Psychological Intervention (EmoEase) in Chinese COPD Patients

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

Background Mental health issues are common and often overlooked in COPD patients. Digital psychological interventions might help, but their effectiveness in Chinese COPD patients hasn't been studied. This study aims to develop and evaluate EmoEase, a digital psychological intervention, for its effectiveness and cost-effectiveness in improving mental wellbeing in Chinese COPD patients. Methods This multicenter, two-arm, randomized controlled trial (RCT) will enroll at least 420 COPD patients over 35 years old. Participants will receive either usual care (control group) or usual care plus EmoEase (intervention group). Assessments will occur at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3). Participants will complete questionnaires and undergo physical measurements. The primary outcome will be mental wellbeing measured by the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes will assess mental and physical health, COPD symptoms, health risk behaviors, socioeconomic factors, and healthcare use and costs. Analyses will use an intention-to-treat approach. Discussion This is the first RCT to evaluate EmoEase for COPD patients. If effective and cost-effective, EmoEase could be scaled up to provide mental health support to COPD patients in China.

NCT ID: NCT05997550 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The Effect of Pursed Lip Breathing Exercise and Laughter Therapy Individuals With The COPD

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease is a chronic disease with increasing mortality, morbidity and prevalence in the world and in our country, and in which serious symptoms, especially dyspnea, develop. Due to dyspnea and symptoms, patients experience deterioration in their health status and an increase in care dependency. This research is a single-blind, randomized controlled experimental study designed to determine the effects of pursed lip breathing exercise and laughter therapy on dyspnea severity, health status and care dependence in individuals with COPD. The research will be carried out with a total of 63 patients in Ankara City Hospital Chest Diseases unit. The patients will be stratified according to smoking status and COPD Assessment Test scores with the randomization program and assigned to 2 intervention groups and 1 control group. During the first interview, patients in the 1st intervention group will be provided with pursed lip breathing exercise training and application, and training videos and brochures will be given. 2. The patients in the intervention group will be given laughter therapy training and practice, and an educational brochure will be given. The patients in the control group will also receive face-to-face training on lung structure and functioning, and a brochure will be given. Patients in the laughter therapy and pursed lip breathing exercise intervention groups will be asked to perform these practices three days a week (Monday, Wednesday, Friday) for 8 weeks. At the beginning of the study, at the 4th, 8th, and 12th weeks, the Dyspnea 12-TR Scale, the COPD Evaluation Test, and the Care Dependency Scale will be administered to both the intervention and control group patients. In the application of the scales and the analysis of the data, the groups will be blinded, and the scale application will be made by an independent interviewer. After the analysis of the data in terms of normal distribution was done with the Kolmogorow Smirnov test, in the comparison of the data of the patients in the intervention and control groups; One Way Analysis of Variance or Kruskal-Wallis Analysis of Variance will be applied. Analysis of Variance in Repeated Measurements or Freidman's test will be used to calculate the change in groups over time. The statistical significance limit will be accepted as p<0.05.

NCT ID: NCT05993364 Not yet recruiting - Clinical trials for Acquired Brain Injury

Efficacy of EFA in Acquired Brain Injury

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.

NCT ID: NCT05986214 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Developing an Intervention to Optimize Virtual Care Adoption for COPD Management

VC-OPTIONS
Start date: March 1, 2026
Phase: N/A
Study type: Interventional

VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.

NCT ID: NCT05975788 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease

Start date: November 2023
Phase: Phase 4
Study type: Interventional

This is a multi-center, prospective study. This study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria Tablets on patients with chronic obstructive pulmonary disease (COPD). In addition, this study investigates the improvement of hospitalization, improvement of pulmonary function, improvement of symptoms, and the use of anti-Infective drugs among COPD patients.