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236 active trials for COPD

Immunization To Prevent Acute COPD Exacerbations

Prospective multicenter observational study, to evaluate the impact of routine clinical practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD exacerbations

Start: November 2017

Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Chronic Obstructive Pulmonary Disease

This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines

Start: June 2020

Chronic Respiratory Disease Burden in Bangladesh

Chronic Respiratory Disease (CRD), particularly asthma and chronic obstructive pulmonary disorders (COPD) are leading causes of mortality and reduced quality of life due to its wide-reported association with other multi-morbidities.There is limited knowledge on the burden of CRD in the rural communities in Bangladesh due to poor awareness on the impact of CRD on quality of life and unavailability of diagnostic facilities due to weaker primary healthcare settings. The study aims to estimate the CRD burden in Bangladesh in a large representative population to draw the attention of policy makers to the creation of social awareness and improvement of primary healthcare infrastructure for respiratory disease in Bangladesh. The study is a prospective observational one in nature. The study will be implemented in Mirzapur, a rural sub-district of Tangail district in Bangladesh within the period of February to May 2021. A total of 981 participants will be enrolled from the study. Verbal consent will be taken initially. Participants who are assessed to be COVID-19 negative will be invited for a visit to the mobile clinic following national health guidelines to perform the spirometry. The study team will provide an information sheet (written in local language) that describes the study aim and objectives with potential risk benefits to the participants. All participants will be enrolled through written consent and satisfactory response to the patient information sheet. The Research Assistant (RA) will collect the relevant metadata such as demographics, information on risk factors, screening questionnaires relevant to asthma and COPD, reported health status and symptoms related to CRD etc. from the participant after obtaining the written consent. Data quality will be ensured by the Field Research Supervisor through checking all the collected information. The enrolled participants will undergo spirometry for the evaluation of their lung function. Spirometry will be collected by trained personnel and will be quality checked by an expert panel at CHRF. Repeated collection will take place in the event if the test results do not pass quality checking. Participant will also be invited to the study clinic within the next 10 days after assessment for any further clinical assessment that is deemed necessary by the study physician. The collected data and spirometry reports will be reviewed to evaluate the CRD patient in terms of their disease. The study will analyse the rate of CRD burden stratified by age, sex, and income group. The productivity loss will be measured in terms of work hours lost due to CRDs.

Start: February 2021

Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD

The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.

Start: April 2021

Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)

The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence

Start: August 2019

Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd

To Evaluate the Outcome of cardio selective beta1 (?1-) blockers use in patients with chronic obstructive pulmonary disease. Patient education about the COPD and their medications.

Start: October 2021

Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients

COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles.

Start: April 2021

Observational Study of Obstructive Lung Disease (NOVELTY)

The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.

Start: July 2016

Screening and Early Warning of Chronic Obstructive Pulmonary Disease Combined With Sleep Respiratory Disease Based on Medical Internet of Things

Chronic obstructive pulmonary disease (COPD) is a common disease that endangers people's health, causing severe economic and treatment burdens. Sleep breathing disease, as a complication of COPD, increases the hospitalization rate and mortality of COPD. At present, community doctors have insufficient knowledge of COPD and its complications, and they also lack standardized screening and related disease management capabilities. This trail intends to use IoT medical technology to screen for COPD combined with sleep breathing diseases. It can establish a two-way referral channel between primary community hospitals and higher-level hospitals, which provides early warning services for COPD combined with sleep breathing diseases. This trial explores the impact of sleep breathing disease on COPD's acute exacerbation, which improves the understanding of COPD patients combined with sleep breathing diseases. It also improves COPD management and its complications control at the community-level and reduces COPD patients' potential risks and treatment burdens. It also explores tiered diagnosis and treatment models for COPD, promotes the construction of intelligent IoT infrastructure, and enhances standardized diagnosis and treatment of COPD at the grassroots level in China.

Start: January 2020

LungVITamin D and OmegA-3 Trial (lungVITAL)

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.

Start: July 2010

Home-monitored Telerehabilitation in COPD Patients

Study title Feasibility and effectiveness of a home monitored rehabilitation intervention using an exergaming approach in COPD patients - a randomized, controlled study. Background and rationale Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease characterized by persistent airflow limitation caused by significant exposure to noxious particles or gases, particularly cigarette smoking. In Sweden the prevalence of COPD is approximately 8% and the annual estimated cost for society of 9.1 billion SEK. Improving exercise capacity and physical activity levels are important goals in management of patients with COPD and are strong determinants of positive outcomes, including increased quality of life. Major barrier for rehabilitation recommendations is the limited access and adherence to organized center-based exercise programs. Major barriers related to the side of health care organization are budgets and infrastructure and the limitation in time of the programs. From patient's perspective major barriers exist, like distance, and lack of transport to the unit, also in relation to the frequency of the program, which is commonly two times a week. Research question and objectives The primary objective of this study is to investigate whether home-based telemonitored supervised exercise programs using an exergaming approach will be associated to improved physical fitness, measured with the (1-minute sit-to-stand test, 1-MSTST) compared to the ordinary care. The secondary objectives of this study are: To investigate whether a home-based exergaming program is associated with improved health-related quality of life, exercise capacity, physical activity levels and body composition. To investigate if the home-based exergaming program is associated with less exacerbations. To investigate if the home-based exergaming program is associated with improved health care utilization and/or less hospitalization from all causes? Study design This is an open label , randomized controlled clinical study. The study takes place at the COPD-center at Sahlgrenska University hospital. Subjects will be randomized to either the use of the ALKIT exergaming tool in combination with telemonitored supervision by a physiotherapist or ordinary care without this system at their first visit. A total of 92 subjects will be included in the study, 46 in every arm. The intervention will include exergames performed 3 times a week for 12 weeks, consistent with the current recommendations. Pre-and post-intervention tests will be performed and subjects in both groups will be assessed. The tests include: 1-minute sit-to-stand test, 6-minute walk test, and timed-up and go. Two self- assessed questionnaires will be filled in: COPD Assessment Test and EQ5D-5L. Subjects will be also measured for quadriceps muscle strength, shoulder flexion and body composition. Additionally, physical activity level will be assessed by outcomes of pedometer worn over a week. Moreover, exacerbations and health care utilization will be measured. Users' perception of the exergaming program will be also investigated. Population and study size The study will include a total of 92 subjects, 46 in the intervention- and 46 in the control arm. For each participant, the total study participation time will be 12 weeks. A randomization list will be produced with random assignment of treatment groups in a ratio of 1:1

Start: March 2021

Revefenacin in Acute Respiratory Insufficiency in COPD

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

Start: November 2020

Inspiration Point-A Digital Pulmonary Rehabilitation Tool Management Interventions

The purpose of this study is to measure the feasibility of use of a digital pulmonary rehabilitation tool compared with standard care home program pulmonary rehabilitation.

Start: November 2020

Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

The VA cares for nearly one million Veterans with COPD at a cost of more than $5.5 billion annually. COPD profoundly impairs quality of life as it limits ability to work, to maintain physical exertion and to engage in social activities. Hospital-based rehab can decrease the need for inpatient and outpatient medical care and can improve exercise capacity, quality of life and, possibly, decrease mortality. Unfortunately, access to hospital-based VA rehab is insufficient and, over time, the few Veterans who attend experience progressive loss of functional gains. The investigators reason that the proposed home-based exercise program augmented by patient-tailored, RAS-enhanced music will overcome the many limitations of hospital-based rehab. Through this innovative program, the investigators expect to enhance the benefits of rehab and better maintain them over time. The easy applicability of this innovative, accessible and economical program has the potential to modify the spiraling pattern of increasing disability and reduce health-care cost and mortality in Veterans with COPD.

Start: October 2018

CALM Breathing for COPD

This study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from our CART (Capnography-Assisted Respiratory Therapy) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.

Start: April 2021

Accessing Mobility Using Wearable Sensors

This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention. The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as Chronic obstructive pulmonary disease (COPD) or Congestive Heart Failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (e.g., LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via tele-medicine (tele-rehabilitation) can enhance motor-cognitive performance.

Start: May 2018

Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of COPD

The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized. Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits. Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.

Start: May 2017

Role of Toilet Bronchoscopy in RICU

Toilet bronchoscopy is a potentially therapeutic intervention to aspirate retained secretions within the endotracheal tube and airways and revert atelectasis. Aspiration of airway secretions is the most common indication to perform a therapeutic bronchoscopy in the intensive care unit (ICU) . Toilet bronchoscopy is particularly beneficial when retained secretions are visible during the procedure and when air-bronchograms are not present at the chest radiograph. It is also beneficial when there is an indication to reverse lobar atelectasis, rather than simply to remove accumulated mucus. Toilet bronchoscopy is used in lobar and complete lung collapse in mechanically ventilated patients who fail to respond to treatments such as physiotherapy or recruitment manoeuvres. The success rates (defined as radiographic improvement on chest X-ray [CXR] or an improved PaO2/PAO2 ratio) in the ICU patient population had. Patients with acute hypoxaemic respiratory failure may already be on non-invasive ventilation (NIV), or require NIV preemptively for Fiberoptic Bronchoscopy (FB). These patients should be considered high risk for requiring intubation post-procedure; therefore, Fiberoptic Bronchoscopy should be performed by an experienced operator in a setting allowing facilities to safely secure the airways. NIV with early therapeutic FB rather than mechanical ventilation can help avoid intubation and reduce tracheostomy rate. Hospital mortality, duration of ventilation, and hospital stay remain similar

Start: July 2021

Virtual Reality as an Adjunct to Management of Pain and Anxiety in Palliative Care

Virtual reality has been shown to be an effective way to treat pain and anxiety in various different settings. Palliative care is an area of medicine that often deals with patients suffering from pain and anxiety. The medication used to manage these symptoms are often opioids and benzodiazepines due to their rapid onset however they do have a significant side effect burden on patients. Very few studies have looked at the effect of virtual reality in this patient population. The goal of this study is to measure if virtual reality can decrease the required amount of medication used in managing pain and anxiety in palliative care. The secondary outcome will look at perceived benefit by patients

Start: October 2020

Atorvastatin Effect on Reduction of COPD Exacerbations

It is a randomized, multicenter, prospective, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 12 Hospital Pulmonary Departments to evaluate the effectiveness of atorvastatin on the reduction of inflammation process in patients with chronic obstructive pulmonary diseases, and possible biomarkers for personalized treatment of COPD.

Start: March 2021