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

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ClinicalTrials.gov Identifier: NCT01260389
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : May 14, 2012
Sponsor:
Collaborators:
University Ghent
GlaxoSmithKline
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: control Behavioral: pharmaceutical care intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 734 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmaceutical Care for COPD Study
Study Start Date : December 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. inhalation technique baseline [ Time Frame: baseline ]
    Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.

  2. inhalation technique 1 month [ Time Frame: after 1 month ]
    Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.

  3. inhalation technique 3 months [ Time Frame: after 3 months ]
    Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.

  4. drug adherence [ Time Frame: after 3 months ]
    Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.


Secondary Outcome Measures :
  1. 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.


  2. health status [ Time Frame: after 1 month ]

    Health status, measured by:

    the COPD Assessment Test, MRC Dyspnoea Scale.


  3. health status [ Time Frame: after 3 months ]

    Health status, measured by:

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


  4. exacerbations [ Time Frame: after 3 months ]
    Frequency of exacerbations measured over a 3 month period.

  5. Emergency Room visits and hospitalizations. [ Time Frame: after 3 months ]
    Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01260389     History of Changes
Other Study ID Numbers: EC/2010/587
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

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

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