Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home (BPCObs)

November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • Nîmes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Experimental group from the hospital
Other: Pharmaceutical consultation at the hospital
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
Experimental: Experimental group from the city
Other: Pharmaceutical consultation at the pharmacy
During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
Other: Follow-up pharmaceutical consultation at the pharmacy
During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Month 3
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.
Month 6
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.
Month 9
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.
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of visits to the attending physician
Time Frame: Month 3
Month 3
Number of visits to the attending physician
Time Frame: Month 6
Month 6
Number of visits to the attending physician
Time Frame: Month 9
Month 9
Number of visits to the attending physician
Time Frame: Month 12
Month 12
Number of visits to the pulmonologist
Time Frame: Month 3
Month 3
Number of visits to the pulmonologist
Time Frame: Month 6
Month 6
Number of visits to the pulmonologist
Time Frame: Month 9
Month 9
Number of visits to the pulmonologist
Time Frame: Month 12
Month 12
Number of visits to the hospital emergency service
Time Frame: Month 3
Month 3
Number of visits to the hospital emergency service
Time Frame: Month 6
Month 6
Number of visits to the hospital emergency service
Time Frame: Month 9
Month 9
Number of visits to the hospital emergency service
Time Frame: Month 12
Month 12
Number of hospitalisation events
Time Frame: Month 3
Month 3
Number of hospitalisation events
Time Frame: Month 6
Month 6
Number of hospitalisation events
Time Frame: Month 9
Month 9
Number of hospitalisation events
Time Frame: Month 12
Month 12
Medication Possession Ratio
Time Frame: 12 months
unit = percent
12 months
Usability score of devices
Time Frame: Month 3
Score between 0 and 3
Month 3
Usability score of devices
Time Frame: Month 6
Score between 0 and 3
Month 6
Usability score of devices
Time Frame: Month 9
Score between 0 and 3
Month 9
Usability score of devices
Time Frame: Month 12
Score between 0 and 3
Month 12
Quality of life questionnaire
Time Frame: Month 1
The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
Month 1
Quality of life questionnaire
Time Frame: Month 6
The quality of life questionnaire BPCO-VQ11 is composed of 11 items. Each item is scored in a 5 point scale.
Month 6
Quality of life questionnaire
Time Frame: Month 12
The quality of life questionnaire BPCO-VQ11 is composed with11 items. Each item is scored in a 5 point scale.
Month 12
device usage learning curve
Time Frame: 12 months
12 months
satisfaction questionnaire
Time Frame: Month 12
This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2017-03/JMK-01
  • 2018-A01699-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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