Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma

Study Overview
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Brief Summary
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Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma. The objective of this study is evaluate the effect of pharmaceutical care on asthma control and quality of life (QoL) of patients with severe or refractory asthma compared with pharmacist dispensation only.

Official Title
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Effect of a 12-month Pharmaceutical Care Program on Severe Asthma Patient. A Randomized Clinical Trial

Conditions
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Asthma, Quality of Life

Intervention / Treatment
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* Other: Pharmaceutical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe/refractory asthma presenting other respiratory disease, ≥ 18 years of age, using high dose of inhaled corticosteroids (≥ 800mcg of budesonide or equivalent) FEV1<60%, regular visitor of the pharmacy and the physicians. Exclusion Criteria: participation in other intervention study during this study, living in other cities, could not participate in all visits of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Dispensing only<br>Non clinical pharmacists will dispense drugs to patients and usual care will be offered. | |
| Experimental: Pharmaceutical care<br>Patients on experimental group will receive counseling and education on the asthma condition, medication and lifestyle issues. In all visits, the inhaler technique will be reviewed, adherence to treatment and drug related problems were checked. If necessary the patient will be referred to the respiratory specialist to change the medication or to prescribe dose adjustment. Pharmacists document their initial and monthly follow up encounters using a specified form. | Other: Pharmaceutical care<br>* Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma control of symptoms | Measured by Asthma Control Questionnaire and medical evaluation | 12 months |