300,000+ clinical trials. Find the right one.

231 active trials for Chronic Obstructive Pulmonary Disease

Social Distancing During the COVID-19 Pandemic and People Living With Chronic Respiratory Diseases

Social distancing during the COVID-19 pandemic could lead to clinical and functional deterioration of people living with chronic respiratory diseases (CRD). As they are considered risk group for COVID-19, it is not recommended that they leave their house and have interaction with people outside. Thus, most of them have not been attend Pulmonary Rehabilitation sections since the beginning of pandemic, neither exercising outdoor, experiencing drastic restrictions in their activities of daily living. It is well known that low level of physical activity in daily life (PADL) in this population is related to poor prognosis, including higher chance of hospitalization due to exacerbation and mortality. Therefore, the aim of this study is to evaluate the short- and mid-term impact of the COVID-19 pandemic on the clinical, physical and functional conditions and the PADL level of people living with CRD (chronic obstructive pulmonary disease, asthma and interstitial lung diseases). Participants will be assessed during the social isolation period and they will be reassessed immediately after release from social isolation. Thus, the subjects will be followed-up during 12 months to record symptoms, functional status, quality of life, exacerbations and hospitalizations. The researchers' hypothesis is that those patients will present very low level of PADL in association to sedentarism, poor functional status, more symptoms of dyspnoea, anxiety and depression, poor sleep quality and, consequently, will present more episodes of acute exacerbation of the disease and more hospital admission during the study protocol.

Start: October 2020

Rehabilitation With HHFNC in COPD in Nocturnal NIV

Humidified High Flow Nasal Cannula (HHFNC), with optional supplemental oxygen delivery, has evolved in recent years with an increasing number of papers that show a better meet with respiratory demand, decrease oxygen dilution, increased Functional Residual Capacity (FRC), dead space washout, more tolerate than Non Invasive Ventilation (NIV) and provide heated and humidified gas. HHFNC is mainly used in intensive care settings or in acute respiratory diseases for the treatment of mild to moderate acute hypoxic respiratory failure and ventilator weaning. The aim of this study is to evaluate, in patients with Chronic Obstructive Pulmonary Disease (COPD) in nocturnal NIV, according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines, whether HHFNC during rehabilitation has an additional effect in increasing the distance in 6 Minute Walking Distance (6MWD) compared to the control group with nocturnal NIV without HHFNC treatment. As secondary objectives, we expect a decrease in Emergency Department (ED) accesses, General Practitioner (GP) unplanned visits, hospitalizations and an improvement of the quality of life and patient satisfaction.

Start: January 2020

A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Current antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline, that has a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD. The investigators aim to conduct a 2-arm, multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

Start: February 2021

Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE)

This study evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

Start: June 2021

Imaging Progression of Chronic Obstructive Pulmonary Disease Using MRI and CT (MR-COPDII)

In this follow-up trial, MRI and CT images of the lung will be acquired prospectively in a subcohort of 370 patients, three years after they successfully participated in the first COSYCONET subtrial with CT and MRI ("MR-COPD I", NCT (clinical.Trials.gov identifier) 02629432). The objective is to obtain longitudinal data from a well-characterized collective of COPD patients in order to identify suitable image-based biomarkers to improve the prognosis of disease progression of COPD in comparison to clinical tests

Start: November 2017

Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)

one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis

Start: November 2020

Physical Activity Promotion Added to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy

In patients with Chronic Obstructive Pulmonary Disease (COPD) daily physical activity is reduced compared to healthy age-matched individuals. Reduced levels of physical activity in patients with COPD are associated with increased risk for exacerbations, hospital admissions and mortality. Pulmonary rehabilitation (PR) constitutes standard care for patients with COPD as it improves exercise capacity, quality of life and reduces the risk for exacerbation and hospitalisation. Participation in PR, however, does not necessarily translate into improved daily physical activity levels. It is currently uncertain whether addition of physical activity promotion strategies to standard PR programs induces an improvement in daily physical activity along with exercise capacity and quality of life compared to pulmonary rehabilitation alone. Physical activity (PA) is a complex health behaviour that is modified by behavioural change interventions. PA promotion programs through the use of wearable monitors (i.e. pedometers, accelerometers) with goal setting and feedback, have shown to increase daily physical activity, but not exercise capacity or quality of life in COPD patients. Therefore, combination of both PR and PA promotion strategies is necessary to translate PR-induced improvements in functional capacity into improved daily physical activity level. The investigators propose to perform a feasibility study assessing patient adherence to PA promotion incorporated into a standard PR program. To enhance adherence to the PA promotion strategy, Cognitive Behavioural Modification Strategies (CBM) will be provided to patients undertaking PR. CBM strategies facilitate the goals of PR as they address several behavioural barriers including anxiety, depression and physical inactivity, and constitutes an important component in the management of COPD to improve engagement with PR and promote a physically active lifestyle. The investigators will divide patients into two programs: one including PR, PA promotion and CBM and the other comprising standard PR and CBM provision. The investigators will compare patients' adherence (16 sessions of PR) to both programs.

Start: November 2018

Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients

Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life. (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

Start: October 2021

Effects of COPD Standardized Management on COPD Exacerbation

This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.

Start: February 2021

Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust

Many "Survivors" in the World Trade Center (WTC) clinical program have a clinical syndrome characterized by chronic obstruction in small airways and persistence of lower respiratory symptoms despite therapy. This study will test the hypothesis that persistent symptoms in WTC "Survivors" are associated with abnormal small airways whose dysfunction is amplified during exercise and is associated with biologic evidence of inflammation and remodeling. The results from this study will have important treatment implications for our WTC population with potential applicability to larger populations with either inhalational lung injury and/or airway diseases such as asthma and chronic obstructive pulmonary disease.

Start: September 2017

Study of AffloVest in At-Risk Respiratory Patients During COVID-19 Pandemic

The purpose of the study is to investigate the addition of high frequency chest wall oscillation (HFCWO) therapy to the prescribed care regimen to support the diaphragm during airway clearance among post-COVID patients with COPD and chronic productive cough as a way to limit the advancement of pulmonary symptoms and need for critical services during recovery from COVID-19.

Start: December 2020

The Mobile COPD Status Test (mCST)

Up tp now, disease activity of COPD patients in their home environment has usually been recorded by questionnaires (e.g. COPD assessment test). Digital multifactorial measurements, via the "mobile COPD Status test" app, offer a new way of displaying disease activity. However, there is no independent study that has examined whether digitally collected parameters correlate with the common used measurement instruments for COPD patients (both in cross-sectional and longitudinal course). The aim of this exploratory study is to investigate the correlation between the mobile COPD Status test (mCST App, KAIA Health) and a conventional collected clinical data set of routine measurements as well as the subjective symptoms and activity perception of COPD patients in their home environment, with and without exacerbation.

Start: August 2020

Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of morbidity and disability with 251 million cases per anum reported worldwide. COPD ranks fourth among the common causes of mortality with an estimated 3 million annual deaths worldwide that is projected to be third by 2020. COPD deaths are more prevalent among the low socio-economic developing countries, estimated up to 90% of the total mortality rate across the globe. In Asia, 13.5% of the total population suffers with COPD. Particularly, in Pakistan every 10th individual suffers with COPD out of which 19.4% are of age above 40 years. Moreover, the problem has been identified as a growing public health concern and a challenge for the clinicians of 21st century. Consequently, the severity of the condition of patients is contributed by exacerbations or co-morbidities, and significant economic burden due to the hospitalizations, absence from work and disability; and its management cost from $1544 to $2335 in Asian countries, annually. However, specific data economic burden for Pakistan is not reported yet. A number of pharmaceutical and non-pharmaceutical treatment options are utilized in the management of COPD; however, pulmonary rehabilitation has been conferred as the corner stone in management of COPD. NICE guidelines emphasize upon the importance of pulmonary rehabilitation for all individuals presenting with COPD; even those who have acutely suffered an exacerbation or underwent recent hospitalization. Moreover, pulmonary rehabilitation consisting of structured exercises regimes and education regarding self-care has been reported to improve COPD symptoms and exercise tolerance; and reduce expenditure of resources on recurrent hospitalization and length of stay. Study has reported that resistance training demonstrated in better improvement in muscular strength than endurance exercise and causes lesser chances of dyspnea while performing activities and is more tolerable than endurance exercise regime. Literature is evident upon that the combination of resistance and endurance training has shown significant improvement in the respiratory parameters. Hence the present study is aimed to incorporate Proprioceptive Neuromuscular Facilitation (PNF) D2 pattern including different types of resistance training in order to determine the response of adjunct therapies on the outcome measures.

Start: October 2020

Effect of Home Exercise Activity on Cortisol and Depression in COPD During the Pandemic COVID

exercise activity during the COVID pandemic is appreciated to be conducted in home especially for chronic chest diseases as chronic obstructive pulmonary disease (COPD) to reduce the chance of viral contamination during the COVID-19 pandemic.

Start: November 2020

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.

Start: June 2021

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Start: June 2021

Residential Cleaning of Indoor Air to Protect COPD Patients

This study looks at whether air cleaning devices put in the bedroom and living room of your home could reduce the irritation of your lungs and body that is caused by indoor air pollution. While participating in this study there will be two, 2 month long study segments (Study Period 1 and Study Period 2) where the air filter units, placed in your living room and bedroom windows, will be turned on at your home.

Start: March 2019

Raman Analysis of Saliva as Biomarker of COPD

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and chronic lung syndrome that causes accelerated lung function decline and death in 20% of cases. The worsening of symptoms, as well as the patient's condition, strictly depends on the identified COPD phenotype, severity stages, exacerbation events, selected drugs, rehabilitation cures and on the adherence of patients to these therapies. Despite the efficient COPD diagnostic procedure, a new fast, sensitive and easily applicable approach must be developed in order to achieve the specific evaluation and monitoring of therapy adherence in COPD patients, stratifying the different COPD phenotypes and foreseeing the exacerbation events in order to optimize the COPD disease management. The application of Raman spectroscopy on saliva has been already proposed for different infective, neurological and cancer diseases, with promising results in the diagnostic and monitoring fields, representing saliva an easy collectable and highly informative biofluid. In this project we propose a combined Raman Spectroscopy - Machine Learning analysis of saliva collected from COPD patients and non-pathological and pathological controls for the development of a multifactorial device able to provide fast and sensitive information regarding COPD phenotypes, exacerbation risks, adherence and effectiveness of pharmacological and rehabilitation therapies, achieving the crucial target of the personalized medicine. Moreover, after the model development, we propose to test the Raman approach in hospital evaluating the creation of a COPD point of care, accompanying the clinicians in the disease management. Starting from FDG preliminary results, the biochemical composition of saliva in patients with diagnosed COPD will be evaluated and statistically compared with the one obtained from age and sex-matched healthy subjects and from patients affected by other respiratory chronic diseases (Asthma). Moreover, an intra-group COPD clustering will be analysed in order to verify a different Raman fingerprint obtained from COPD patients with different phenotypes. The collected Raman data will be processed using a multivariate analysis approach. The classification model will be created using cross-validation and subset validation. Thanks to RS, the overall composition of saliva will be established with minimal sample preparation, providing a comprehensive biochemical fingerprint of the sample. The expected results are I) Identification of the specific COPD Raman fingerprint through the comparison with healthy subjects and patients affected by asthma; II) Monitoring of the therapy adherence through the drug signal and/or biochemical modification in saliva; III) Stratification of the 4 COPD phenotypes on the base of the provided Raman fingerprint; IV) Monitoring of the rehabilitation procedures and effects; V) Association of an high exacerbation risk index to specific COPD patients; VI) Creation of a classification model of the created Raman database.

Start: October 2020

The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients

The aim of this study is to investigate the effects of changes in foot structure on physical activity level, fatigue and quality of life in COPD patients.

Start: March 2021

Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies

This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and quantifiable) autoimmune responses. The primary goal is to determine effects of belimumab on levels of autoantibodies against glucose regulated protein 78 (GRP78) among patients with pulmonary emphysema attributable to cigarette smoking. The investigators hypothesize that belimumab treatment will safely reduce circulating levels of autoantibodies that are associated with emphysema, and comorbidities of this lung disease, including atherosclerosis.

Start: August 2018