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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT04683952 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Rehabilitation With HHFNC in COPD in Nocturnal NIV

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04639349 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

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

Start date: November 19, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04636814 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

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)

PILLAR
Start date: July 12, 2021
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04636801 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

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)

PILASTER
Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04628962 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Raman Analysis of Saliva as Biomarker of COPD

CORSAI
Start date: February 1, 2022
Phase:
Study type: Observational

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and chronic lung syndrome that causes accelerated lung function decline and death in the 20% of cases. Mostly, the non-adherence to therapy contributes to symptoms increase, mortality, inability and therapies failure, highly influencing the management costs associated to COPD. The existing procedure of diagnosing COPD is effective and fast. The acute treatment and the subsequent disease management, instead, strictly depend on the currently long and complex process of identification of three factors: COPD phenotype, adherence to chosen therapy and probability of exacerbation events. The knowledge of these factors is needed by clinicians to stratify patients and personalise the therapies and rehabilitation procedures, to initiate an effective disease management. The application of Raman spectroscopy on saliva, representing an easy collectable and highly informative biofluid, has been already proposed for different infective, neurological and cancer diseases, with promising results in the diagnostic and monitoring fields. In this project, we propose the use of Deep Learning analysis of Raman spectra collected from COPD patient's saliva to be combined with other clinical data for the development of a system able to provide fast and sensitive information regarding COPD phenotypes, adherence and exacerbation risks. This will support clinicians to personalise COPD therapies and treatments, and to monitor their effectiveness.

NCT ID: NCT04571983 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Influence of Reliance on Historical Blood Eosinophil Counts on ICS Prescribing by GOLD 2019 Thresholds in COPD

BECCOPD
Start date: October 26, 2020
Phase:
Study type: Observational

Blood eosinophils are a type of white blood cell that helps fight infection. They have a number of different functions but are primarily involved in numerous inflammatory processes. They are recruited from the blood into sites of inflammation. In patients with COPD, higher blood eosinophil count (BEC) predicts a greater reduction in moderate and severe exacerbations in response to inhaled corticosteroid (ICS) therapy. The Global Initiative for Chronic Obstructive Lung Disease strategy (GOLD 2019) recommends the use of BEC to guide ICS therapy and states that eosinophil levels above 300 cells/μL can help identify responders, guiding initial dual therapy, with "little or no effect at a BEC < 100 cells/μL". The National Institute for Health and Care Excellence (NICE) COPD 2018 guideline states that a higher BEC is associated with ICS response, but does not specify a threshold. Earlier research studies have suggested that at lower levels of BEC the harm of ICS due to pneumonia is greater than the benefit of severe exacerbation reduction. Patients with COPD can have "flare ups" of their disease known as exacerbations. Blood eosinophils play a critical role in assessing severity of these exacerbations and guiding management. The association between BEC and reduction in exacerbation frequency is based on BEC measured when the patient is clinically stable. Transient low eosinophil count (eosinopenia with BEC < 50 cells/μL) during severe exacerbation is extremely common. In the Dyspnoea, Eosinopenia, Consolidation, Acidaemia and atrial Fibrillation (DECAF) score derivation and validation studies combined, eosinopenia was present on admission in 1,340 of 2,645 severe exacerbations of COPD (ECOPD) and is associated with longer length of stay, higher in-hospital and one year mortality. Although eosinophilic COPD exacerbations occur, overall BEC during moderate or severe exacerbation is lower than stable state. In ECOPD managed in critical care low BEC is associated with higher rate of septic shock and mortality. BEC are also suppressed during other acute illnesses, notably sepsis. Failure to recognise that BEC are often suppressed during acute illness compared to stable state may lead to ICS therapy being inappropriately withheld. The effect of exacerbation and other acute illnesses on eosinophils is under-appreciated. Both NICE and GOLD guidelines fail to mention whether BEC should be prospectively measured when patients are stable (reflecting RCT evidence), or if reliance on historical values is acceptable. In routine practice some clinicians rely on previous BECs to avoid a delay in treatment decisions. A number of these historical counts will have been taken during illness, underestimating the patients' stable-state BEC. Conversely, COPD is associated with other medical conditions, and BEC may be requested for reasons other than acute illness. Using the highest BEC from multiple measures in the previous 24 months may therefore better agree with stable state counts. The primary aim of this trial is to assess the reliability of using BEC over the preceding 24 months to assess COPD eosinophil phenotype at both GOLD thresholds. The primary outcome will be based on using the highest of at least three BEC. Secondary outcomes include a) the level of agreement between baseline stable state BEC and both mean and the highest BEC over the preceding 24 months, b) the influence of the number of BEC measures available and c) the effect of limiting the time frame from 24 months to the previous 12 months. BEC is associated with disease severity, providing further evidence that COPD eosinophil phenotype may change over time. As an exploratory analysis, periods of sustained change in eosinophil phenotype will be sought, and the relationship between eosinophil phenotype and patient characteristics and certain medication will be assessed. The investigators will also assess the relations between the dependent variables stable state absolute eosinophil and basophil counts and both eosinophil to basophil and neutrophil to lymphocyte ratios and the following clinical outcomes: a) moderate and severe exacerbations and b) mortality. Some of these variables have previously been shown to be related to disease severity and mortality.

NCT ID: NCT04550741 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

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

m-Rehab COPD
Start date: March 10, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04536675 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery

Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

This is a double-blind randomized controlled trial evaluating the effect of perioperative dual bronchodilator therapy on post-operative pulmonary function and health-related quality of life (QoL) in mild-to-moderate less symptomatic COPD patients undergoing lung cancer surgery. Investigators hypothesized that dual bronchodilator, as compared with placebo, would prevent reduction of pulmonary function after surgical resection and improve postoperative health related QoL.

NCT ID: NCT04529993 Recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

An Atlas of Airways at a Single Cell Level in Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Controls

DISCOVAIR
Start date: November 18, 2020
Phase: N/A
Study type: Interventional

The increasing incidence of chronic respiratory disease is a public health problem that affects hundreds of thousands of people worldwide at all ages. Directly exposed to atmospheric airborne contaminants (pollution, allergens), the respiratory tract represents a complex ecosystem involving different cells (multiciliated, basal, mucosecretory, neuroendocrine, etc.) that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and the local microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, investigators have demonstrated large gene expression gradients between samples taken from the nasal and bronchial airways in different studies. Specifying the cellular variability throughout the respiratory tree in a normal physiological situation is one of the major objectives defined in the establishment of an atlas of all airway cells, as defined in the objectives of the international consortium Human Cell Atlas. The sequencing of the RNAs present specifically in each individual cell ("single-cell RNAseq"), and its comparison with neighbouring cells allows to document the precise cellular contributions, as well as the signalling pathways involved. The development of tissue sampling, stabilization, transport and single cell analysis procedures can be performed on primary respiratory epithelium cultures and can also be extended to respiratory samples from healthy volunteers. This project will analyze gene expression profiles at the single cell level (single cell RNAseq) in volunteers with chronic obstructive pulmonary disease, interstitial pulmonary fibrosis and compared to healthy subjects of the same age. The technical modalities of the samples will be brushing and staged airway biopsies for direct analysis of the samples. This approach will be complemented by an air-liquid interface culture to allow secondary analysis in single cell RNAseq and three-dimensional mapping of the distribution of these cells with single cell in situ analysis. Thanks to sampling at several levels of the respiratory tree (nose, bronchioles, bronchioles), cellular and gene expression variations along the tracheobronchial axis will be exhaustively documented in subjects of different ages, healthy or suffering from pathologies such as chronic obstructive pulmonary disease and interstitial pulmonary fibrosis. These data will serve as worldwide references for comparisons in different physiological and pathological contexts.

NCT ID: NCT04520568 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery

Start date: August 1, 2020
Phase: Phase 2
Study type: Interventional

High-flow nasal cannula (HFNC) is a device that delivers10 to 70 L min-1 of heated, humidified 100% oxygen via nasal route. It provides positive airway pressure, decreases dyspnea, decreases the work of breathing, and improves comfort