Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— PHARMACOPOfficial title:
Pharmaceutical Care for COPD Study
NCT number | NCT01260389 |
Other study ID # | EC/2010/587 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2010 |
Est. completion date | July 2011 |
Verified date | July 2021 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University | Ghent | |
Belgium | Centre Hospitalier Universitaire du Sart Tilman | Liege |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | GlaxoSmithKline, University Ghent |
Belgium,
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 |
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