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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT04361552 Withdrawn - Clinical trials for Coronary Artery Disease

Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Start date: April 7, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

NCT ID: NCT04088942 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol

TOB-STOP-COP
Start date: July 1, 2023
Phase: Phase 4
Study type: Interventional

Background: Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD) and it contributes to the development of many other serious diseases. Acute exacerbations of COPD (AECOPD) often lead to hospitalization. Severe hospitalization-requiring AECOPD carries very high economic costs for the healthcare system, and personal costs for patients. Smoking cessation in COPD for the healthcare system, and personal costs for patients. Smoking cessation in COPD patients is known to improve survival and reduce the number of AECOPD. However, smoking cessation interventions in these patients have only been successful for consistent smoking abstinence in 12 months in approximately 15-20%. Thus, more effective interventions are needed for this patient group. Aims: The aim of this study is to determine, among people with chronic obstructive pulmonary disease (COPD), whether a "high-intensive" smoking cessation intervention in comparison to a standard intervention can lead to permanent, >12 months, smoking cessation in a higher proportion. Methods: This study is a randomized trial in active smokers with COPD and who have lost less than 50% lung function. A total of 600 participants will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation programme, "low intensity" group), or an intervention group ("high-intensity" group), which consists of group sessions, telephone consultations, behavior design, hotline, "buddy-matching" (smoker matched with COPD patient who stopped). Both groups will receive pharmacological smoking cessation. Discussion: The potential benefit of this project is to prevent smoking-related exacerbations of COPD and thereby reduce logistics and costs of hospitalization and treatment of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of developing lung cancer and other smoking-related diseases.

NCT ID: NCT04087369 Withdrawn - Hypertension Clinical Trials

Integrated NCD Intervention in Rural Nepal

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

We will test an NCD intervention bundle incorporating the World Health Organisation (WHO)'s Package for Essential Non-Communicable Disease Interventions (PEN) within an approximate population of 300,000 people in rural Nepal. This intervention integrates three evidence-based approaches for both facility- and community-based NCD care focused on the key areas of Clinical Practice, Counseling, and Technology for two tiers of non-physician healthcare worker - Mid-Level Providers and Community Health Workers: 1) Task-shifting of evidence-based medicine algorithms and clinical skills from PEN protocols to non-physician healthcare workers; 2) Delivering quality counseling based on the Motivational Interviewing Model to drive behavior change with respect to both treatment adherence (defined as medication adherence and follow-up completion) and risk factor modification (alcohol, tobacco, diet, physical activity); 3) Employing a facility- and community-based clinical decision support tool for effective integration of PEN protocols into non-physician healthcare worker workflow. This five-year study will initial test the acceptability and feasibility of the intervention (two years) followed by a type 2 hybrid effectiveness-implementation research trial (three years) to which we will apply the RE-AIM implementation evaluative framework of both outcomes and process indicators. Co-primary outcomes for the intervention bundle will be: a) disease-specific, evidence-based control metrics that measures clinical efficacy; b) qualitative evaluation of acceptability and feasibility that incorporates perspectives of patients, providers, and government stakeholders; and c) an implementation checklist of key intervention process measures.

NCT ID: NCT04066751 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

The Multicenter Topic Trial

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this protocol is to test the safety, pharmacokinetics, and pharmacodynamics of the Cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, ivacaftor in patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. This project will investigate the hypothesis that ivacaftor can augment CFTR activity in individuals with COPD who exhibit chronic bronchitis, resulting in meaningful improvements in epithelial function and respiratory health. The study is a multicenter, randomized, double-blind, placebo-controlled, stratified study of orally-administered ivacaftor.

NCT ID: NCT04042168 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 25, 2019
Phase: Phase 4
Study type: Interventional

Using various types of inhalers is the treatment cornerstone for COPD patients to control their symptoms. Many inhaler devices require minimum inspiratory effort to activate the device, COPD patients commonly use such devices. Those devices deliver the medications only when the patient forcefully inhales so the drug can reach the lungs, thus exerting their therapeutic action. The effect of appropriate use of the inhalers in patients with COPD is not well studied, and the impact of demonstrating that a patient can inhale forcefully enough to activate a device on its' effect on symptoms is also lacking in the medical literature. The purpose of this study is to find out: 1. the frequency of COPD patients demonstrating an appropriate use of inhalers that have flow-triggered systems, 2. whether the appropriate use of inhalers impacts the Quality of Life and Shortness of Breath of COPD patients, and 3. the impact of appropriate use of inhalers on FEV1 in COPD patients.

NCT ID: NCT03653104 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot

MELODY
Start date: June 12, 2018
Phase: N/A
Study type: Interventional

This project seeks to pilot-test the feasibility of using a melodica training program to teach pursed lip breathing for Veterans with chronic obstructive pulmonary disease (COPD) with moderate to severe dyspnea (shortness of breath). Dyspnea occurs commonly among COPD patients and can limit activities of daily living. Pursed lip breathing is a strategy that can improve dyspnea and exercise capacity among COPD patients. The melodica is a musical instrument that looks like a keyboard with a mouthpiece on the side. The melodica is played by exhaling through the mouthpiece while pressing the keys. The MELODY pilot project protocol has been grounded on concepts from occupational therapy; specifically, providing participants with a meaningful new activity that is enjoyable, that can be provided across a spectrum of skill levels, that can provide participants with a new sense of self, and that can improve health outcomes (i.e., dyspnea and exercise endurance).

NCT ID: NCT03489746 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Steroid Withdrawal Intervention in Fife and Tayside

SWIFT
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The SWIFT trial is a cluster randomised trial to determine if a patient identification, feedback and inhaled corticosteroid (ICS) withdrawal intervention in primary care can result in more appropriate inhaled corticosteroid use without increasing the frequency of exacerbations. Practices in Tayside and Fife will be randomised at practice level to an intervention or control. The intervention will consist of electronic review of patients Chronic obstructive pulmonary disease (COPD) data and prescribing history, followed by implementation of a medication change involving withdrawal of ICS and introduction of a Long acting beta adrenergic agonist (LABA) and Long acting muscarinic antagonist (LAMA) for patients without an indication for ongoing ICS treatment. Patients in control practices will not receive the intervention, but practices will be provided with local guidelines and formulary and encouraged to prescribe appropriately. Patients in the control practices may be switched to guideline compliant medications. Our hypothesis is that removal of non-evidence barriers to appropriate prescribing will result in in high rates of ICS withdrawal and that the intervention will be safe, as evidenced by no increase in the frequency of exacerbations over 12 months of follow-up.

NCT ID: NCT03385317 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Mindfulness to Mitigate the Effect of Anxiety-depression-fear in Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 2016
Phase: N/A
Study type: Interventional

People with COPD have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. Those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. There is a lack of treatment options to be routinely used in primary clinics for patients with COPD. Systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in COPD patients, especially breathing-related anxiety. Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD targeted to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a mindfulness coach using a combination of in-person sessions and remote video call sessions will be effective in improving emotional and overall quality of life, and measured physical activity.

NCT ID: NCT03323190 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

An Educational Intervention to Improve Disease Management Knowledge of Hospitalized Patients With COPD

Start date: August 30, 2016
Phase: N/A
Study type: Interventional

The objective of this study is to determine if inpatient COPD education would result in improved patient knowledge of COPD.

NCT ID: NCT03181880 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease

ASTUTE
Start date: December 4, 2017
Phase: Phase 4
Study type: Interventional

ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.