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).

Severe Lung Disease in Childhood

Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few. This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.

Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered hip exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.