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

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: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Pharmaceutical consultation at the hospital; Other: Pharmaceutical consultation at the pharmacy; Other: Follow-up pharmaceutical consultation at the pharmacy

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of visits to the attending physician		Month 3
Number of visits to the attending physician		Month 6
Number of visits to the attending physician		Month 9
Number of visits to the attending physician		Month 12
Number of visits to the pulmonologist		Month 3
Number of visits to the pulmonologist		Month 6
Number of visits to the pulmonologist		Month 9
Number of visits to the pulmonologist		Month 12
Number of visits to the hospital emergency service		Month 3
Number of visits to the hospital emergency service		Month 6
Number of visits to the hospital emergency service		Month 9
Number of visits to the hospital emergency service		Month 12
Number of hospitalisation events		Month 3
Number of hospitalisation events		Month 6
Number of hospitalisation events		Month 9
Number of hospitalisation events		Month 12
Medication Possession Ratio	unit = percent	12 months
Usability score of devices	Score between 0 and 3	Month 3
Usability score of devices	Score between 0 and 3	Month 6
Usability score of devices	Score between 0 and 3	Month 9
Usability score of devices	Score between 0 and 3	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.	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.	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.	Month 12
device usage learning curve		12 months
satisfaction questionnaire	This questionnaire is composed with 4 questions. Each item is scored in a 4 point scale.	Month 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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