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NCT00263159 Clinical Trial

Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study

Asthma Clinical Trial

Official title:
Pharmaceutical Care for Asthma Control Improvement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00263159
Other study ID # 2005/320
Secondary ID
Status Completed
Phase N/A
First received December 6, 2005
Last updated December 19, 2007
Start date January 2006
Est. completion date October 2006

Study information
Verified date December 2007
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.

Description:

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Patients will be randomly allocated to the control group (= no input from pharmacist) or intervention group (= with pharmaceutical care at baseline and follow-up visits over 6 months).

Recruitment information / eligibility
Status Completed
Enrollment 221
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients with persistent asthma

- Asthma treatment for at least 12 months

- Regular visitors of the participating community pharmacy

Exclusion Criteria:

- Severe co-morbidity

- > 10 pack-years smoking history

- Asthma Control Test score < 15 or =25

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Procedure:
• Pharmaceutical care for asthma patients

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary The difference between study groups in the change of asthma control from baseline and follow-up visits after 1, 3 and 6 months
Secondary Peak flow after 3 and 6 months
Secondary Knowledge of asthma and treatment after 6 months
Secondary Asthma quality of life questionnaire (AQLQ) after 6 months
Secondary Therapy adherence
Secondary Inhalation techniques after 6 months
Secondary Smoking after 6 months
Secondary Asthma exacerbations after 6 months
Secondary General Practitioner (GP) visits, emergency room visits and hospitalisations
Secondary Working days lost and school days lost
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