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

This study has been completed.
Sponsor:
Collaborators:
University Ghent
GlaxoSmithKline
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01260389
First received: December 13, 2010
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
 Behavioral: control
Behavioral: pharmaceutical care intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmaceutical Care for COPD Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • inhalation technique baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.

  • inhalation technique 1 month [ Time Frame: after 1 month ] [ Designated as safety issue: No ]
    Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.

  • inhalation technique 3 months [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.

  • drug adherence [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.


Secondary Outcome Measures:
  • health status [ Time Frame: baseline ] [ Designated as safety issue: No ]

    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.


  • health status [ Time Frame: after 1 month ] [ Designated as safety issue: No ]

    Health status, measured by:

    the COPD Assessment Test, MRC Dyspnoea Scale.


  • health status [ Time Frame: after 3 months ] [ Designated as safety issue: No ]

    Health status, measured by:

    the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire.


  • exacerbations [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    Frequency of exacerbations measured over a 3 month period.

  • Emergency Room visits and hospitalizations. [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.


Enrollment: 734
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD).
 Behavioral: control
usual pharmacist care
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).

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260389

Locations
Belgium
Ghent University
Ghent, Belgium
Centre Hospitalier Universitaire du Sart Tilman
Liege, Belgium
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
GlaxoSmithKline
Investigators
Principal Investigator: Guy Brusselle, M.D. , Ph.D. University Hospital, Ghent
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01260389     History of Changes
Other Study ID Numbers: EC/2010/587
Study First Received: December 13, 2010
Last Updated: May 11, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013