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Completed

NCT Number: NCT01260389

Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmaceutical care intervention

Behavioral

Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • GlaxoSmithKline
  • University Ghent

Registry information

Official study title

Pharmaceutical Care for COPD Study

Acronym: PHARMACOP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2010
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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