Clinical Research Directory

Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.

In 2020, chronic obstructive pulmonary disease (COPD) was the 4th leading cause of death worldwide. In France, its annual cost was estimated at 4366 euros per patient, including 25% related to management of exacerbations and 33% to hospitalization. In 2014, the prevalence of COPD in France was estimated at 7.5% of the population. Projections of the epidemiological evolution of COPD systematically predict an increase in the prevalence of moderate to very severe COPD, notably due to an increase among women and subjects aged ≥ 75 years. Management of COPD patients is multi-dimensional and multi-professional. In January 2020, the French National Authority for Health (HAS) issued recommendations for comprehensive management of COPD, including smoking cessation, influenza and pneumococcal vaccinations, therapeutic training on the use of inhalation devices, and pulmonary function tests. In 2022, the French health insurance scheme also measured quality indicators to assess the care pathway for COPD patients. Among these indicators, two concerned the care of stable patients: influenza vaccination, performed on only 52.7% of patients, and PFT or annual spirometry in 34.2% of patients. Indicators concerning post-hospitalization follow-up were also deemed insufficient, with only 41.9% of patients receiving medical follow-up within 7 days of hospitalization for COPD exacerbation, and 30.9% receiving follow-up by a pulmonologist within 60 days. Recently, in 2023, an observational study was conducted at Nîmes University Hospital, and is currently under review for publication. The study aimed to assess the profile of hospitalized COPD patients, as well as compliance with HAS recommendations. Of the 85 patients included, 59 (69.5%) had a COPD-VQ-11 score ≥ 22, reflecting poor COPD-related quality of life, and 30 (35.3%) were not followed by a pulmonologist. Twenty-five patients had not stopped smoking (32.9%), and pneumococcal vaccination coverage was only 34% (10% in patients not followed by a pulmonologist).Thanks to their daily presence and expertise in care departments, hospital clinical pharmacists can do targeted interventions tailored to individual patients. For example, during a hospital stay they can identify shortcomings in the care of certain chronic diseases and, if necessary, intervene with the patient or the care team. Clinical pharmacists can also take part in day hospitalizations (DHs) by doing pharmaceutical consultations with patients. Since 2021, a respiratory insufficiency DH has been set up at Nîmes University Hospital. This DH, coordinated by an advanced practice nurse (APN), enables multi-professional reassessment of the care of COPD patients, and targeted interventions such as PFTs or stress tests, vaccination prescriptions, help with quitting smoking and training on the use of inhalation devices. Based on these findings, and using the tools and resources available at Nîmes University Hospital, the aim is to evaluate the impact of a structured, multi-disciplinary care process for hospitalized COPD patients, focusing on changes in their quality of life, a reflection of their state of health, as well as on their care pathway. The hypothesize is that this targeted intervention will improve patients' COPD-related quality of life, and reduce mortality, exacerbations, hospitalizations, cardiovascular events, emergency room visits and consultations with general practitioners. This intervention could also improve smoking cessation and vaccination coverage. Finally, the medico-economic efficiency of this process will be assessed via a cost-utility analysis. The national supply of care for certain chronic diseases is currently limited and saturated, leading to difficulties in management and medical follow-up, and resulting in an unfavorable trend in patients' state of health. This study aims to repond to that problem, focusing on COPD, to assess the feasibility and effectiveness of a structured, multidisciplinary care concept hitherto never implemented in this region. Such an approach could make it possible to detect patients suffering from chronic diseases not only like COPD, but also heart failure or diabetes, and optimize their care through interventions and the organization of a dedicated care pathway. This care would be based on the various clinical pharmacy missions carried out during the hospital stay, and the deployment of optimized DH pathways for high-performance global care. This pilot study aims to obtain the initial indicators required to set up future comparative multicenter studies with a high level of evidence on efficacy and costs.

Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

This is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging,14-day dosing, 2-period crossover study in participants with chronic obstructive pulmonary disease (COPD).

THERMotherapy Against Persistent Bacterial LUNG Infections

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

TCM Daoyin Therapy in Individuals At-risk for COPD

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on Individuals at-risk for COPD.

Cough Capture as a Portal Into the Lung

The lung is a privileged organ; blood does not reflect most lung processes well, if at all. Therefore, for population scale diagnostics, the investigator team is developing non-invasive portals to the lung, for eventual early detection/risk assessment and diagnostic purposes. However, large macromolecules are not likely suspended nor readily detected in the breath. In particular, genomic DNA in the breath condensate (EBC) is very sparse, and where present, generally highly fragmented, not readily amenable to sequencing based assessments of DNA somatic mutation burden or distribution. Because gDNA (and protein) is challenging to obtain non-invasively from EBC, the study team considered alternative surrogate lower airway specimens. Cough capture is rarely done, and the investigator team is in the process of optimizing its collection. Importantly, the team will be evaluating how much of coughed material is from saliva contamination. Additionally, analyzing material that is target captured by capturing deep lung extracellular vesicles (EVs) using immobilized CCSP/SFTPC antibodies targeting EVs from distal bronchiole Club and alveolar type 2 cells could circumvent the mouth contamination problem, leaving a non-invasive portal to the deep lung suitable for large molecules, and in turn suitable for myriad epidemiologic and clinical applications. The investigator team proposes (Aim 1) to pursue optimizing cough collection, and testing the efficacy and practicality of partitioning cough specimen for deep-lung specific extra-cellular vesicles (EVs). This cough specimen will be compared to that from invasively collected deep lung samples BAL/bronchial brushings, and to the potential contaminating mouth rinse, all from the same individuals. (Aim 2) The study team initially proposes to examine these cough specimens for somatic mutations by SMM bulk sequencing for single nucleotide variation, developed in the Vijg/Maslov labs. Finally, the investigator team will (Aim 3) test all airway specimens (cough, mouthwash and BAL) for lung surrogacy of cough, using proteins known to be specific for lung, as opposed to oral cavity/saliva, in the Sidoli/proteomics core. The investigator team envisions that the translational impact of non-invasively obtained DNA or protein markers could allow for more rapid acute clinical diagnoses, and facilitate precision prevention and/or early detection of many acute and chronic respiratory disorders, including lung cancer, asthma and COPD, acute and chronic infectious diseases, and indeed systemic disorders of inflammation and metabolism.

Efficacy of EFA in Acquired Brain Injury

Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.

Antibiotic Stewardship in AECOPD Through CRP-Guided Management

Objectives: To determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD health status with usual care. Hypothesis to be tested: (i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups. Design and subjects: Multi-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A\&E. Instruments: Clinical COPD Questionnaire and EuroQol-5D Interventions: Both intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP \>5mg/dL. Once CRP has declined to \<5mg/dL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered. Communication with Receiving Ward Staffs: Participants in the study may transfer to another departments after treatment/ care in A\&E. The following communication would be conducted: * A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A\&E. The note would also suggest the investigations for the receiving ward staffs. * Telephone handover about intervention group and investigations of the study, and treatments given in A\&E to ward. Main outcome measures: The antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation. Data analysis: Intention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation. Expected results: The intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.