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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT06175065 Recruiting - Clinical trials for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Start date: January 25, 2024
Phase: Phase 2
Study type: Interventional

AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.

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: NCT06172946 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Powerbreath Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke. POWERbreathe device (POWER-breathe International Ltd., Southam, Warwickshire, UK) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. Also, the POWER-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in COPD patients. Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. NMES applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (TEDS).

NCT ID: NCT06172712 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A

CSA
Start date: May 8, 2024
Phase:
Study type: Observational

This work is a multicentric prospective cohort study designed to improve chronic obstructive pulmonary disease (COPD) treatment and management. The study involves 150 patients diagnosed with COPD who are at risk of exacerbations. These patients are recruited from three tertiary hospitals in Spain, Germany, and Italy. The study will last 18 months, with a 12-month follow-up duration for each patient. The primary objective of this study is to develop and test Artificial Intelligence (AI)-based models that can predict moderate-to-severe COPD exacerbations early on. This will be done by analyzing daily-life data collected from unobtrusive sensors that monitor patients' psycho-physiological and environmental signals. By accurately predicting exacerbations, the study aims to support clinicians in providing more precise, optimized, and personalized treatment to COPD patients. A secondary objective is to train and test AI-based models to estimate the 12-month dynamics of health-related quality of life (HRQoL) in COPD patients. This will involve analyzing data related to the patients' functional exercise capacity, dyspnea (difficulty breathing), and health-related quality of life, as measured by the Clinical COPD Questionnaire (CCQ) score and the COPD Assessment Test (CAT) score.

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: NCT06163131 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility

Start date: November 27, 2023
Phase:
Study type: Observational

In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. The diaphragm is the muscle used for breathing between the chest and the stomach. Some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness. The goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. The main questions it aims to answer are: - If the movement of the diaphragm improves after treatment with endobronchial valves. - If there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability. - If ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment. Participants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.

NCT ID: NCT06160674 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Vowel Segmentation for Classification of Chronic Obstructive Pulmonary Disease Using Machine Learning

Start date: November 28, 2023
Phase:
Study type: Observational [Patient Registry]

This work aims to evaluate whether the segmentation of vowel recordings collected from patients diagnosed with COPD and healthy control groups can increase the classification precision of machine learning techniques.

NCT ID: NCT06158633 Not yet recruiting - Dialysis Clinical Trials

A Pilot Observation and Feasibility Study of Prevora, Integrated Into Homecare Visits of High-risk Adults

Start date: December 2023
Phase:
Study type: Observational

Prevora is an antiseptic medication and dental treatment approved by Health Canada for reducing root decay (cavities) in adults at high risk of dental decay. An antiseptic kills germs and harmful bacteria. Prevora is applied to the teeth and gumline by a medical professional, takes about 10 minutes and is painless. Participating site(s) have a homecare program and usual care includes offering patients home care services before discharge from the hospital for some chronic diseases. Usual care includes home visits by a nurse and or personal support worker (PSW). The aim of this study is to explore the effectiveness, health benefits and feasibility of delivering preventive oral healthcare with Prevora, during a homecare visit by a nurse or PSW. All consenting and eligible subjects will continue with their usual care with the homecare program. The study is 5 months long. Subjects will have a Prevora treatment applied by the homecare nurse or PSW on Day 1, 14 days, 3 months and 4 months. The study includes several follow up visits which will be conducted in the patient's home and or by telephone or videoconferencing if needed. Oral exams, lab tests and subject completed questionnaires will be collected for the study. Changes in medications and any possible side effects will also be monitored during the study.

NCT ID: NCT06154837 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

Start date: November 27, 2023
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).

NCT ID: NCT06149494 Recruiting - Copd Clinical Trials

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection

Start date: November 20, 2023
Phase: Phase 2
Study type: Interventional

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.