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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— PHARMACOP  

Official title:

Pharmaceutical Care for COPD Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260389
• Other study ID #: EC/2010/587
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Belgium	Centre Hospitalier Universitaire du Sart Tilman	Liege

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Ghent	GlaxoSmithKline, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inhalation technique baseline	Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.	baseline
Primary	inhalation technique 1 month	Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.	after 1 month
Primary	inhalation technique 3 months	Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.	after 3 months
Primary	drug adherence	Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.	after 3 months
Secondary	health status	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
Secondary	health status	Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale.	after 1 month
Secondary	health status	Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire.	after 3 months
Secondary	exacerbations	Frequency of exacerbations measured over a 3 month period.	after 3 months
Secondary	Emergency Room visits and hospitalizations.	Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.	after 3 months

External Links

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