Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study

December 19, 2007 updated by: University Ghent

Pharmaceutical Care for Asthma Control Improvement

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference between study groups in the change of asthma control from baseline and follow-up visits
Time Frame: after 1, 3 and 6 months
after 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Therapy adherence
Peak flow
Time Frame: after 3 and 6 months
after 3 and 6 months
Knowledge of asthma and treatment
Time Frame: after 6 months
after 6 months
Asthma quality of life questionnaire (AQLQ)
Time Frame: after 6 months
after 6 months
Inhalation techniques
Time Frame: after 6 months
after 6 months
Smoking
Time Frame: after 6 months
after 6 months
Asthma exacerbations
Time Frame: after 6 months
after 6 months
General Practitioner (GP) visits, emergency room visits and hospitalisations
Working days lost and school days lost

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005/320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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