Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (COPD) Study. (PHARMACOP)

July 7, 2021 updated by: University Hospital, Ghent

Pharmaceutical Care for COPD Study

This study would like to test the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in Chronic Obstructive Pulmonary Disease (COPD) patients over a 3 month-period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effective pharmacologic management of Chronic Obstructive Pulmonary Disease (COPD) not only involves prescription of recommended medicines by the physician, but also implies correct use of the prescribed medication by the patient (ie, good drug adherence and correct inhalation technique). Community pharmacists could help to improve the latter aspect, by delivering pharmaceutical care. The present randomised controlled trial will study the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in COPD patients over a 3 month-period.

Study Type

Interventional

Enrollment (Actual)

734

Phase

  • 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

  • Belgium
      • Ghent, Belgium
        • Ghent University
      • Liege, Belgium
        • Centre Hospitalier Universitaire du Sart Tilman

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • daily use of Chronic Obstructive Pulmonary Disease (COPD)-medication: (Global initiative for chronic Obstructive Lung Disease: GOLD stadia I-IV)
  • 50 years of age or older
  • smoking history of at least 10 pack-years

Exclusion Criteria:

  • having asthma
  • analphabetism

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD).
Experimental: pharmaceutical care intervention
A pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).
Behavioral: pharmaceutical care intervention
Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inhalation technique baseline
Time Frame: baseline
Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.
baseline
inhalation technique 1 month
Time Frame: after 1 month
Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.
after 1 month
inhalation technique 3 months
Time Frame: after 3 months
Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.
after 3 months
drug adherence
Time Frame: after 3 months
Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.
after 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health status
Time Frame: baseline

Health status, measured by:

the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test, Medical Research Council (MRC) Dyspnoea Scale and Euro Quality of Life (EQ-5D) questionnaire.
baseline
health status
Time Frame: after 1 month

Health status, measured by:

the COPD Assessment Test, MRC Dyspnoea Scale.
after 1 month
health status
Time Frame: after 3 months

Health status, measured by:

the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire.
after 3 months
exacerbations
Time Frame: after 3 months
Frequency of exacerbations measured over a 3 month period.
after 3 months
Emergency Room visits and hospitalizations.
Time Frame: after 3 months
Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.
after 3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

GlaxoSmithKline
University Ghent

Investigators

  • Principal Investigator: Guy Brusselle, M.D., Ph.D., University Hospital, Ghent

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.

Helpful Links

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

December 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2010/587

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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