Chronic Obstructive Pulmonary DiseaseOPTI-BPCONCT07907601
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
A study testing COPD targeted pharmaceutical interview and consultation, Respiratory Insufficiency Day Hospitalization and Pulmonary Function Test in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive, Lung Disease Chronic
- What is being tested?
- COPD targeted pharmaceutical interview and consultation, Respiratory Insufficiency Day Hospitalization and Pulmonary Function Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD. A patient will be considered to have COPD if he or she meets all the following criteria: 1) active or former smoker > 1 packet per day for 10 years; 2) history of COPD mentioned in the medical record; 3) treated with at least one inhalation device.
- Patient hospitalized at Nimes University Hospital (besides the Pneumology department).
- Patients not benefiting from a regular pneumology follow-up (i.e. less than one visit per year).
- Patients able to self-manage his/her COPD.
- Patients with a life-expectancy of at least 12 months.
- Affiliated person or beneficiary of a social security scheme.
- Free, written, informed consent signed by the participant and the investigator.
Who cannot join
- Patients hospitalized in the Pneumology Department.
- Patients hospitalized for COPD exacerbation.
- Patients with heart failure and LVEF < 30%.
- Cancer patients undergoing chemotherapy or palliative care.
- WHO stage 4 patients.
- Patients taking part in an interventional drug study.
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- Patients in an exclusion period determined by another study.
- Patients under court protection, guardianship or curatorship.
- Patients unable to give consent.
- Patients for whom it is impossible to provide information.
- Pregnant or breast-feeding patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Nîmes University Hospital
Nîmes, Gard, 30029
Florent DUBOIS, Dr., +33 44.66.68.31.04, florent.dubois@chu-nimes.fr
Anissa MEGZARI, 0466684236, drc@chu-nimes.fr
About this study
Official title: Evaluation of the Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway. A Prospective Monocentric Randomized Controlled Pilot Study
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.
Read the detailed description
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.
- Being tested
- COPD targeted pharmaceutical interview and consultation, Respiratory Insufficiency Day Hospitalization, Pulmonary Function Test
- Keywords
- Lung disease, Respiratory disease, Smoking, Streptococcus pneumoniae
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases, Respiration Disorders, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD targeted pharmaceutical interview and consultationOther
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
Respiratory Insufficiency Day HospitalizationOther
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.
Pulmonary Function TestOther
Also called Spirometry
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.
| Study group | Role | What they receive |
|---|---|---|
| OPTI-BPCO" (experimental) group | Experimental | 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. Receives: Other: COPD targeted pharmaceutical interview and consultation; Other: Respiratory Insufficiency Day Hospitalization; Other: Pulmonary Function Test |
| Standard management (control) group | No intervention | The patients in this group will receive the standard care for COPD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Secondary outcomes (42)
A. Forced Expiratory Volume in 1 second in the control group
Spirometry
Measured: Baseline
A. Forced Expiratory Volume in 1 second in the experimental group
Spirometry
Measured: Baseline
A. Forced Expiratory Volume in 1 second in the control group
Spirometry
Measured: At 12 months
A. Forced Expiratory Volume in 1 second in the experimental group
Spirometry
Measured: 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
- I get short of breath when hurrying on level ground or walking up a slight hill
- 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
- I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
- I am too breathless to leave the house or I am breathless when dressing
Measured: 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
- I get short of breath when hurrying on level ground or walking up a slight hill
- 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
- I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
- I am too breathless to leave the house or I am breathless when dressing
Measured: 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
- I get short of breath when hurrying on level ground or walking up a slight hill
- 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
- I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
- I am too breathless to leave the house or I am breathless when dressing
Measured: 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
- I get short of breath when hurrying on level ground or walking up a slight hill
- 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
- I stop for breath after walking about 100 yards [91 meters] or after a few minutes on level ground
- I am too breathless to leave the house or I am breathless when dressing
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
D. Mortality in the control group
Number of deaths
Measured: At 6 months
D. Mortality in the experimental group
Number of deaths
Measured: At 6 months
D. Mortality in the control group
Number of deaths
Measured: At 12 months
D. Mortality in the experimental group
Number of deaths
Measured: At 12 months
E. Incidence of exacerbations in the control group
Number of exacerbations
Measured: At 6 months
E. Incidence of exacerbations in the experimental group
Number of exacerbations
Measured: At 6 months
E. Incidence of exacerbations in the control group
Number of exacerbations
Measured: At 12 months
E. Incidence of exacerbations in the experimental group
Number of exacerbations
Measured: At 12 months
F. Incidence of hospitalizations in the control group
Quantitative
Measured: At 6 months
F. Incidence of hospitalizations in the experimental group
Quantitative
Measured: At 6 months
F. Incidence of hospitalizations in the control group
Quantitative
Measured: At 12 months
F. Incidence of hospitalizations in the experimental group
Quantitative
Measured: At 12 months
G. Number of consultations in the control group
Quantitative
Measured: At 6 months
G. Number of consultations in the experimental group
Quantitative
Measured: At 6 months
G. Number of consultations in the control group
Quantitative
Measured: At 12 months
G. Number of consultations in the experimental group
Quantitative
Measured: At 12 months
H. Incidence of cardio-vascular complications in the control group
Quantitative
Measured: At 6 months
H. Incidence of cardio-vascular complications in the experimental group
Quantitative
Measured: At 6 months
H. Incidence of cardio-vascular complications in the control group
Quantitative
Measured: At 12 months
H. Incidence of cardio-vascular complications in the experimental group
Quantitative
Measured: At 12 months
I. Smoking cessation in the control group
Number of patients who were smokers at baseline and have now quit smoking
Measured: At 6 months
I. Smoking cessation in the experimental group
Number of patients who were smokers at baseline and have now quit smoking
Measured: At 6 months
I. Smoking cessation in the control group
Number of patients who were smokers at baseline and have now quit smoking
Measured: At 12 months
I. Smoking cessation in the experimental group
Number of patients who were smokers at baseline and have now quit smoking
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Pharmacoeconomic impact in the control group
Pharmacoeconomic impact: estimation of the cost the care pathway concerning hospitalizations.
Measured: At 12 months
Pharmacoeconomic impact in the experimental group
Pharmacoeconomic impact: estimation of the cost the care pathway concerning hospitalizations.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Implementation of a targeted multidisciplinary approach known as "OPTI-BPCO" (experimental group) versus standard management (control group). Patients will be randomized to one or the other group in a 1:1 ratio. Randomization will be stratified according to quality of life (BPCO VQ 11 score \< 22 or ≥ 22).
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Sihame CHKAIR, Principal investigator, Nîmes University HospitalClément CARBASSE, Dr., Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907601
- Sponsor's protocol ID
- CIVI/2025/FD-01
- Acronym
- OPTI-BPCO
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway. A Prospective Monocentric Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07907601
- Acronym / sponsor ID
- OPTI-BPCO / CIVI/2025/FD-01
- Keywords
- Lung disease, Respiratory disease, Smoking, Streptococcus pneumoniae
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Implementation of a targeted multidisciplinary approach known as "OPTI-BPCO" (experimental group) versus standard management (control group). Patients will be randomized to one or the other group in a 1:1 ratio. Randomization will be stratified according to quality of life (BPCO VQ 11 score < 22 or ≥ 22).
| Arm | Type | Receives |
|---|---|---|
| OPTI-BPCO" (experimental) group | Experimental | Other: COPD targeted pharmaceutical interview and consultation, Other: Respiratory Insufficiency Day Hospitalization, Other: Pulmonary Function TestThe 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. |
| Standard management (control) group | No intervention | –The patients in this group will receive the standard care for COPD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with COPD. A patient will be considered to have COPD if he or she meets all the following criteria: 1) active or former smoker > 1 packet per day for 10 years; 2) history of COPD mentioned in the medical record; 3) treated with at least one inhalation device.
- Patient hospitalized at Nimes University Hospital (besides the Pneumology department).
- Patients not benefiting from a regular pneumology follow-up (i.e. less than one visit per year).
- Patients able to self-manage his/her COPD.
- Patients with a life-expectancy of at least 12 months.
Key exclusion criteria (11 listed)
- Patients hospitalized in the Pneumology Department.
- Patients hospitalized for COPD exacerbation.
- Patients with heart failure and LVEF < 30%.
- Cancer patients undergoing chemotherapy or palliative care.
- WHO stage 4 patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD targeted pharmaceutical interview and consultationStandardized 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 | Other | OPTI-BPCO" (experimental) group |
| Respiratory Insufficiency Day HospitalizationPatients 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. | Other | OPTI-BPCO" (experimental) group |
| Pulmonary Function TestAlso: SpirometryThe 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. | Other | OPTI-BPCO" (experimental) group |
Primary outcome
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Control group
Time frame: Baseline
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.
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Experimental group
Time frame: Baseline
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.
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Control group
Time frame: At 12 months
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.
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Experimental group
Time frame: At 12 months
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.
42 secondary outcomes
A. Forced Expiratory Volume in 1 second in the control group
Time frame: Baseline
A. Forced Expiratory Volume in 1 second in the experimental group
Time frame: Baseline
A. Forced Expiratory Volume in 1 second in the control group
Time frame: At 12 months
A. Forced Expiratory Volume in 1 second in the experimental group
Time frame: At 12 months
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the control group
Time frame: Baseline
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the experimental group
Time frame: Baseline
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the control group
Time frame: At 12 months
B.Dyspnea in the control group according to the Modified Medical Research Council (mMRC) scale in the experimental group
Time frame: At 12 months
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the control group
Time frame: Baseline
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the experimental group
Time frame: Baseline
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the control group
Time frame: At 12 months
C. Symptoms of COPD according to the COPD Assessment Test (CAT) score in the experimental group
Time frame: At 12 months
D. Mortality in the control group
Time frame: At 6 months
D. Mortality in the experimental group
Time frame: At 6 months
D. Mortality in the control group
Time frame: At 12 months
D. Mortality in the experimental group
Time frame: At 12 months
E. Incidence of exacerbations in the control group
Time frame: At 6 months
E. Incidence of exacerbations in the experimental group
Time frame: At 6 months
E. Incidence of exacerbations in the control group
Time frame: At 12 months
E. Incidence of exacerbations in the experimental group
Time frame: At 12 months
F. Incidence of hospitalizations in the control group
Time frame: At 6 months
F. Incidence of hospitalizations in the experimental group
Time frame: At 6 months
F. Incidence of hospitalizations in the control group
Time frame: At 12 months
F. Incidence of hospitalizations in the experimental group
Time frame: At 12 months
G. Number of consultations in the control group
Time frame: At 6 months
G. Number of consultations in the experimental group
Time frame: At 6 months
G. Number of consultations in the control group
Time frame: At 12 months
G. Number of consultations in the experimental group
Time frame: At 12 months
H. Incidence of cardio-vascular complications in the control group
Time frame: At 6 months
H. Incidence of cardio-vascular complications in the experimental group
Time frame: At 6 months
H. Incidence of cardio-vascular complications in the control group
Time frame: At 12 months
H. Incidence of cardio-vascular complications in the experimental group
Time frame: At 12 months
I. Smoking cessation in the control group
Time frame: At 6 months
I. Smoking cessation in the experimental group
Time frame: At 6 months
I. Smoking cessation in the control group
Time frame: At 12 months
I. Smoking cessation in the experimental group
Time frame: At 12 months
J. Rate of pneumococcal vaccination in the control group
Time frame: Baseline
J. Rate of pneumococcal vaccination in the experimental group
Time frame: Baseline
J. Rate of pneumococcal vaccination in the control group
Time frame: At 12 months
J. Rate of pneumococcal vaccination in the experimental group
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sihame CHKAIR principal investigator
Nîmes University Hospital
Clément CARBASSE, Dr. principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD targeted pharmaceutical interview and consultation, Respiratory Insufficiency Day Hospitalization and Pulmonary Function Test in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent DUBOIS, Dr. (+33 44.66.68.31.04, florent.dubois@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of a targeted and multidisciplinary approach on the quality of life of COPD patients at 12-month follow-up. Control group (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.