An interventional study of COPD targeted pharmaceutical interview and consultation and Respiratory Insufficiency Day Hospitalization in Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive and Lung Disease Chronic, sponsored by Centre Hospitalier Universitaire de Nīmes. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Supportive care
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.
Chronic obstructive pulmonary disease (COPD) is a chronic, irreversible respiratory illness with a poor prognosis, associated with several comorbidities such that its burden on quality of life is heavy. In 2009, its prevalence was estimated at 7.6% of the world's population, with the elderly the most affected, accounting for 14.2% of people over 65. In 2020 it was the 4th leading cause of death worldwide, and projections put it in 3rd place. In France, its annual cost was estimated at 4366 euros per patient, including 25% related to the 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, aimed at slowing the progression of the disease and improving patients' quality of life, is multi-dimensional and multi-professional. In January 2020, with this in mind, the French National Authority for Health (HAS) issued recommendations for comprehensive management of the disease. These include 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 management 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 medical 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 carried out at Nîmes University Hospital, and is currently under review for publication. The aim of the study was to assess the profile of hospitalized COPD patients, as well as compliance with HAS management 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 quitted 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 carry out targeted interventions tailored to individual patients, in addition to their usual tasks such as medication conciliation and pharmaceutical analysis. During a hospital stay, for example, they can identify shortcomings in the care of certain chronic diseases and, if necessary, intervene with the patient or the care team.
As part of their new missions, clinical pharmacists can also take part in day hospitalizations (DHs) by doing pharmaceutical consultations with patients. For example, 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 could improve patients' COPD-related quality of life, and reduce mortality, exacerbations, hospitalizations, cardiovascular events, emergency room visits and consultations with general practitioners (GPs). This intervention could improve smoking cessation and vaccination coverage among patients. Finally, the medico-economic efficiency of this process will be assessed via a cost-utility analysis. More generally, 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. It is in response to this problem that this study, focusing on COPD, aims 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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 116 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients in this group will receive the standard care as well as structured multidisciplinary management of COPD, including both a targeted COPD pharmaceutical interview and consultation during the hospital stay, and a multidisciplinary "respiratory insufficiency" HDJ three months after hospital discharge.
Other: COPD targeted pharmaceutical interview and consultation · Other: Respiratory Insufficiency Day Hospitalization · Other: Pulmonary Function Test
The patients in this group will receive the standard care for COPD.
Standardized follow-up checklist, tested in an observational study of targeted interviews (publication in progress) and validated by the Pharmacy and Pneumology teams at Nîmes University Hospital. Evaluation of the efficiency of placebo inhalation devices vs. devices from patient's own treatment. Data collection for use in the "respiratory insufficiency hospitalization day program
Patients in the OPTI-BPCO group will be hospitalized for one day in order for them to receive consultations with a pulmonomogist, a clinical pharmacist, and an advanced practice nurse.
The patient is asked to put on soft nose clips to prevent air escape and a breathing sensor in their mouth forming an air tight seal. Guided by a technician, the patient is given step-by-step instructions to take an abrupt maximum effort inhale, followed by a maximum effort exhale lasting for a target of at least 6 seconds. When assessing possible upper airway obstruction, the technician will direct the patient to make an additional rapid inhalation to complete the round. The timing of the second inhale can vary between persons depending on the length of the preceding exhale. In some cases each round of test will be preceded by a period of normal, gentle breathing for additional data.
Also known as: Spirometry
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Control group
Difference between the quality-of-life score based on the BPCO-VQ-11 questionnaire given at inclusion and after 12-month follow-up. A first questionnaire will be completed by the patient at inclusion, directly in the care department. A second questionnaire will be completed by the patient at 12 months, during a follow-up visit for consultation with an advanced practice nurse.
Time frame: Baseline
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Experimental group
Difference between the quality-of-life score based on the BPCO-VQ-11 questionnaire given at inclusion and after 12-month follow-up. A first questionnaire will be completed by the patient at inclusion, directly in the care department. A second questionnaire will be completed by the patient at 12 months, during a follow-up visit for consultation with an advanced practice nurse.
Time frame: Baseline
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Control group
Difference between the quality-of-life score based on the BPCO-VQ-11 questionnaire given at inclusion and after 12-month follow-up. A first questionnaire will be completed by the patient at inclusion, directly in the care department. A second questionnaire will be completed by the patient at 12 months, during a follow-up visit for consultation with an advanced practice nurse.
Time frame: At 12 months
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Experimental group
Difference between the quality-of-life score based on the BPCO-VQ-11 questionnaire given at inclusion and after 12-month follow-up. A first questionnaire will be completed by the patient at inclusion, directly in the care department. A second questionnaire will be completed by the patient at 12 months, during a follow-up visit for consultation with an advanced practice nurse.
Time frame: At 12 months
A. Forced Expiratory Volume in 1 second in the control group
Spirometry
Time frame: Baseline
A. Forced Expiratory Volume in 1 second in the experimental group
Spirometry
Time frame: Baseline
A. Forced Expiratory Volume in 1 second in the control group
Spirometry
Time frame: At 12 months
A. Forced Expiratory Volume in 1 second in the experimental group
Spirometry
Time frame: At 12 months
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the control group
The Modified Medical Research Council (mMRC) scale is a self-administered scale ranging from 0 to 4, by means of which patients evaluate their breathlessness as follows: 0 I only get breathless with strenuous exercise 1. I get short of breath when hurrying on level ground or walking up a slight hill 2. On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace 3. I stop for breath after walking about 100 yards \[91 meters\] or after a few minutes on level ground 4. I am too breathless to leave the house or I am breathless when dressing
Time frame: Baseline
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the experimental group
The Modified Medical Research Council (mMRC) scale is a self-administered scale ranging from 0 to 4, by means of which patients evaluate their breathlessness as follows: 0 I only get breathless with strenuous exercise 1. I get short of breath when hurrying on level ground or walking up a slight hill 2. On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace 3. I stop for breath after walking about 100 yards \[91 meters\] or after a few minutes on level ground 4. I am too breathless to leave the house or I am breathless when dressing
Time frame: Baseline
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the control group
The Modified Medical Research Council (mMRC) scale is a self-administered scale ranging from 0 to 4, by means of which patients evaluate their breathlessness as follows: 0 I only get breathless with strenuous exercise 1. I get short of breath when hurrying on level ground or walking up a slight hill 2. On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace 3. I stop for breath after walking about 100 yards \[91 meters\] or after a few minutes on level ground 4. I am too breathless to leave the house or I am breathless when dressing
Time frame: At 12 months
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the experimental group
The Modified Medical Research Council (mMRC) scale is a self-administered scale ranging from 0 to 4, by means of which patients evaluate their breathlessness as follows: 0 I only get breathless with strenuous exercise 1. I get short of breath when hurrying on level ground or walking up a slight hill 2. On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace 3. I stop for breath after walking about 100 yards \[91 meters\] or after a few minutes on level ground 4. I am too breathless to leave the house or I am breathless when dressing
Time frame: At 12 months
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the control group
The COPD Assessment Test (CAT) score is obtained via a questionnaire containing 8 questions regarding the patient's symptoms of COPD graded from 0 (not at all) to 5 (very much). The total score is the sum of the patient's answers to all 8 questions.
Time frame: Baseline
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the experimental group
The COPD Assessment Test (CAT) score is obtained via a questionnaire containing 8 questions regarding the patient's symptoms of COPD graded from 0 (not at all) to 5 (very much). The total score is the sum of the patient's answers to all 8 questions.
Time frame: Baseline
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the control group
The COPD Assessment Test (CAT) score is obtained via a questionnaire containing 8 questions regarding the patient's symptoms of COPD graded from 0 (not at all) to 5 (very much). The total score is the sum of the patient's answers to all 8 questions.
Time frame: At 12 months
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the experimental group
The COPD Assessment Test (CAT) score is obtained via a questionnaire containing 8 questions regarding the patient's symptoms of COPD graded from 0 (not at all) to 5 (very much). The total score is the sum of the patient's answers to all 8 questions.
Time frame: At 12 months
D. Mortality in the control group
Number of deaths
Time frame: At 6 months
D. Mortality in the experimental group
Number of deaths
Time frame: At 6 months
D. Mortality in the control group
Number of deaths
Time frame: At 12 months
D. Mortality in the experimental group
Number of deaths
Time frame: At 12 months
E. Incidence of exacerbations in the control group
Number of exacerbations
Time frame: At 6 months
E. Incidence of exacerbations in the experimental group
Number of exacerbations
Time frame: At 6 months
E. Incidence of exacerbations in the control group
Number of exacerbations
Time frame: At 12 months
E. Incidence of exacerbations in the experimental group
Number of exacerbations
Time frame: At 12 months
F. Incidence of hospitalizations in the control group
Quantitative
Time frame: At 6 months
F. Incidence of hospitalizations in the experimental group
Quantitative
Time frame: At 6 months
F. Incidence of hospitalizations in the control group
Quantitative
Time frame: At 12 months
F. Incidence of hospitalizations in the experimental group
Quantitative
Time frame: At 12 months
G. Number of consultations in the control group
Quantitative
Time frame: At 6 months
G. Number of consultations in the experimental group
Quantitative
Time frame: At 6 months
G. Number of consultations in the control group
Quantitative
Time frame: At 12 months
G. Number of consultations in the experimental group
Quantitative
Time frame: At 12 months
H. Incidence of cardio-vascular complications in the control group
Quantitative
Time frame: At 6 months
H. Incidence of cardio-vascular complications in the experimental group
Quantitative
Time frame: At 6 months
H. Incidence of cardio-vascular complications in the control group
Quantitative
Time frame: At 12 months
H. Incidence of cardio-vascular complications in the experimental group
Quantitative
Time frame: At 12 months
I. Smoking cessation in the control group
Number of patients who were smokers at baseline and have now quit smoking
Time frame: At 6 months
I. Smoking cessation in the experimental group
Number of patients who were smokers at baseline and have now quit smoking
Time frame: At 6 months
I. Smoking cessation in the control group
Number of patients who were smokers at baseline and have now quit smoking
Time frame: At 12 months
I. Smoking cessation in the experimental group
Number of patients who were smokers at baseline and have now quit smoking
Time frame: At 12 months
J. Rate of pneumococcal vaccination in the control group
Percentage of patients not vaccinated at inclusion who were vaccinated against pneumococcus during the 12-month follow-up.
Time frame: Baseline
J. Rate of pneumococcal vaccination in the experimental group
Percentage of patients not vaccinated at inclusion who were vaccinated against pneumococcus during the 12-month follow-up.
Time frame: Baseline
J. Rate of pneumococcal vaccination in the control group
Percentage of patients not vaccinated at inclusion who were vaccinated against pneumococcus during the 12-month follow-up.
Time frame: At 12 months
J. Rate of pneumococcal vaccination in the experimental group
Percentage of patients not vaccinated at inclusion who were vaccinated against pneumococcus during the 12-month follow-up.
Time frame: At 12 months
Pharmacoeconomic impact in the control group
Pharmacoeconomic impact: estimation of the cost the care pathway concerning hospitalizations.
Time frame: At 12 months
Pharmacoeconomic impact in the experimental group
Pharmacoeconomic impact: estimation of the cost the care pathway concerning hospitalizations.
Time frame: At 12 months
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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