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Lung Diseases clinical trials

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NCT ID: NCT04088942 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease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NCT ID: NCT04066751 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease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: NCT03949842 Withdrawn - Clinical trials for Pulmonary Disease, Chronic Obstructive

Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study

LEGEND
Start date: June 27, 2019
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a non-randomized, interventional and self-controlled cohort study conducted to collect data in routine practice. This study will have two periods where in retrospective data will be collected in pre-switch period and prospective data will be collected in post-switch periods. Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300 subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.

NCT ID: NCT03799588 Withdrawn - Lung Diseases Clinical Trials

Transmitted Lung Pressures With Biphasic Chest Cuirass

Start date: January 8, 2019
Phase: N/A
Study type: Interventional

This study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.

NCT ID: NCT03673579 Withdrawn - Stress Clinical Trials

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB

Start date: June 14, 2018
Phase: N/A
Study type: Interventional

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

NCT ID: NCT03673566 Withdrawn - Stress Clinical Trials

Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO

Start date: March 20, 2019
Phase: N/A
Study type: Interventional

This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. Clinicians will be asked to follow their current standard of care practices with the aid of this technology. About half of participants will receive care in NICU rooms with the Dashboard installed while the other half will receive standard care without the Dashboard.

NCT ID: NCT03569774 Withdrawn - Obesity Clinical Trials

Individualized vs Low PEEP in One Lung Ventilation

Start date: August 14, 2018
Phase: N/A
Study type: Interventional

The aim of the prospective crossover study is to investigate the effect of individualized positive end-expiratory pressure (PEEP) on measures of tissue oxygenation, compared with low PEEP.

NCT ID: NCT03532334 Withdrawn - Lung Diseases Clinical Trials

Comparison of 133Xe Scintigraphy With 19F MRI

Start date: April 4, 2018
Phase: Early Phase 1
Study type: Interventional

The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy

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.