Chronic Obstructive Pulmonary DiseaseBPCObsNCT03704545
Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
A study testing Pharmaceutical consultation at the hospital, Pharmaceutical consultation at the pharmacy and Follow-up pharmaceutical consultation at the pharmacy in people with Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pharmaceutical consultation at the hospital, Pharmaceutical consultation at the pharmacy and Follow-up pharmaceutical consultation at the pharmacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2019to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The patient has signed the consent form.
- The patient is affiliated to a health insurance programme
- The patient is at least 18 years old (≥).
- The patient is admitted to complete hospitalization (for patients in the "Hospital and Control" groups).
- The patient is diagnosed with stage 2 to 4 Chronic Obstructive Pulmonary Disease. The diagnosis as well as the stage of the disease are validated by a pulmonologist at the facility.
- The patient has one or more inhaler devices to treat Chronic Obstructive Pulmonary Disease.
- The patient returns to his / her home when discharged from hospital (for patients in the "Hospital and Control" groups).
- The patient is available for a follow-up of 12 months.
Who cannot join
- The subject participates in another interventional study.
- The subject is in an exclusion period determined by a previous study.
- The patient is under safeguard of justice.
- The subject refuses to sign the consent.
- It is not possible to give the patient (or his/her trusted-person) informed information.
Trial locations and contacts
1 site in 1 country.
About this study
The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pharmaceutical consultation at the hospital, Pharmaceutical consultation at the pharmacy, Follow-up pharmaceutical consultation at the pharmacy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical consultation at the hospitalOther
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
Pharmaceutical consultation at the pharmacyOther
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
Follow-up pharmaceutical consultation at the pharmacyOther
During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Experimental group from the hospital | Experimental | Not described Receives: Other: Pharmaceutical consultation at the hospital |
| Experimental group from the city | Experimental | Not described Receives: Other: Pharmaceutical consultation at the pharmacy; Other: Follow-up pharmaceutical consultation at the pharmacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbation events
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Measured: Month 3
Number of exacerbation events
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Measured: Month 6
Number of exacerbation events
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Measured: Month 9
Number of exacerbation events
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Measured: Month 12
Secondary outcomes (26)
Number of visits to the attending physician
Measured: Month 3
Number of visits to the attending physician
Measured: Month 6
Number of visits to the attending physician
Measured: Month 9
Number of visits to the attending physician
Measured: Month 12
Number of visits to the pulmonologist
Measured: Month 3
Number of visits to the pulmonologist
Measured: Month 6
Number of visits to the pulmonologist
Measured: Month 9
Number of visits to the pulmonologist
Measured: Month 12
Number of visits to the hospital emergency service
Measured: Month 3
Number of visits to the hospital emergency service
Measured: Month 6
Number of visits to the hospital emergency service
Measured: Month 9
Number of visits to the hospital emergency service
Measured: Month 12
Number of hospitalisation events
Measured: Month 3
Number of hospitalisation events
Measured: Month 6
Number of hospitalisation events
Measured: Month 9
Number of hospitalisation events
Measured: Month 12
Medication Possession Ratio
unit = percent
Measured: 12 months
Usability score of devices
Score between 0 and 3
Measured: Month 3
Usability score of devices
Score between 0 and 3
Measured: Month 6
Usability score of devices
Score between 0 and 3
Measured: Month 9
Usability score of devices
Score between 0 and 3
Measured: Month 12
Quality of life questionnaire
The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
Measured: Month 1
Quality of life questionnaire
The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
Measured: Month 6
Quality of life questionnaire
The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale.
Measured: Month 12
device usage learning curve
Measured: 12 months
satisfaction questionnaire
This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start18 Jan 2019
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704545
- Sponsor's protocol ID
- NIMAO/2017-03/JMK-01
- Other IDs
- 2018-A01699-46
- Acronym
- BPCObs
- Status last verified
- Jan 2023
- First submitted
- 10 Oct 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hachemi D, Leguelinel-Blache G, Bouvet S, Roux-Marson C, Plouvier N, Kinowski JM, Castelli C, Dubois F. Clinical impact of pharmaceutical consultations in patients treated for chronic obstructive pulmonary disease: Study protocol for a randomized controlled trial (BPCObs study). Contemp Clin Trials Commun. 2023 Dec 20;37:101249. doi: 10.1016/j.conctc.2023.101249. eCollection 2024 Feb.
PubMed 38269046
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home
- ClinicalTrials.gov ID
- NCT03704545
- Acronym / sponsor ID
- BPCObs / NIMAO/2017-03/JMK-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 12 Oct 2018 (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.
The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Experimental group from the hospital | Experimental | Other: Pharmaceutical consultation at the hospital |
| Experimental group from the city | Experimental | Other: Pharmaceutical consultation at the pharmacy, Other: Follow-up pharmaceutical consultation at the pharmacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient has signed the consent form.
- The patient is affiliated to a health insurance programme
- The patient is at least 18 years old (≥).
- The patient is admitted to complete hospitalization (for patients in the "Hospital and Control" groups).
- The patient is diagnosed with stage 2 to 4 Chronic Obstructive Pulmonary Disease. The diagnosis as well as the stage of the disease are validated by a pulmonologist at the facility.
Key exclusion criteria (5 listed)
- The subject participates in another interventional study.
- The subject is in an exclusion period determined by a previous study.
- The patient is under safeguard of justice.
- The subject refuses to sign the consent.
- It is not possible to give the patient (or his/her trusted-person) informed information.
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 |
|---|---|---|
| Pharmaceutical consultation at the hospitalDuring 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use. | Other | Experimental group from the hospital |
| Pharmaceutical consultation at the pharmacyDuring 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use. | Other | Experimental group from the city |
| Follow-up pharmaceutical consultation at the pharmacyDuring 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use. | Other | Experimental group from the city |
Primary outcome
Number of exacerbation events
Time frame: Month 3
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Number of exacerbation events
Time frame: Month 6
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Number of exacerbation events
Time frame: Month 9
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
Number of exacerbation events
Time frame: Month 12
Exacerbation events will be defined as any episode of increased respiratory symptoms, especially dyspnea, cough and sputum production, and increased sputum purulence.
26 secondary outcomes
Number of visits to the attending physician
Time frame: Month 3
Number of visits to the attending physician
Time frame: Month 6
Number of visits to the attending physician
Time frame: Month 9
Number of visits to the attending physician
Time frame: Month 12
Number of visits to the pulmonologist
Time frame: Month 3
Number of visits to the pulmonologist
Time frame: Month 6
Number of visits to the pulmonologist
Time frame: Month 9
Number of visits to the pulmonologist
Time frame: Month 12
Number of visits to the hospital emergency service
Time frame: Month 3
Number of visits to the hospital emergency service
Time frame: Month 6
Number of visits to the hospital emergency service
Time frame: Month 9
Number of visits to the hospital emergency service
Time frame: Month 12
Number of hospitalisation events
Time frame: Month 3
Number of hospitalisation events
Time frame: Month 6
Number of hospitalisation events
Time frame: Month 9
Number of hospitalisation events
Time frame: Month 12
Medication Possession Ratio
Time frame: 12 months
Usability score of devices
Time frame: Month 3
Usability score of devices
Time frame: Month 6
Usability score of devices
Time frame: Month 9
Usability score of devices
Time frame: Month 12
Quality of life questionnaire
Time frame: Month 1
Quality of life questionnaire
Time frame: Month 6
Quality of life questionnaire
Time frame: Month 12
device usage learning curve
Time frame: 12 months
satisfaction questionnaire
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 38269046Hachemi D, Leguelinel-Blache G, Bouvet S, Roux-Marson C, Plouvier N, Kinowski JM, Castelli C, Dubois F. Clinical impact of pharmaceutical consultations in patients treated for chronic obstructive pulmonary disease: Study protocol for a randomized controlled trial (BPCObs study). Contemp Clin Trials Commun. 2023 Dec 20;37:101249. doi: 10.1016/j.conctc.2023.101249. eCollection 2024 Feb.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical consultation at the hospital, Pharmaceutical consultation at the pharmacy and Follow-up pharmaceutical consultation at the pharmacy in people with Chronic Obstructive Pulmonary Disease, 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 4 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exacerbation events (time frame: Month 3). 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?
On the ClinicalTrials.gov record for NCT03704545, which also lists 1 linked publication.
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 4 Dec 2025.