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

NCT03704545 | Completed

• 2 other identifiers: NIMAO/2017-03/JMK-012018-A01699-46
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (26)

• 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

Study Arms (3)

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

Interventions

Pharmaceutical consultation at the hospital OTHER

During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.

Experimental group from the hospital

Pharmaceutical consultation at the pharmacy OTHER

During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.

Experimental group from the city

Follow-up pharmaceutical consultation at the pharmacy OTHER

During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.

Experimental group from the city

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject participates in another interventional 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 38269046 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 12, 2018
• Study Start: January 18, 2019
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: December 4, 2025

Record last verified: 2023-01

Locations

FR (1)