- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644357
Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma
Effect of a 12-month Pharmaceutical Care Program on Severe Asthma Patient. A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pablo M Santos, master
- Phone Number: 55 71 3283-8085
- Email: pablomoura@ufba.br
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40060-330
- Program for Asthma Control (ProAR) of the Federal University of Bahia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Dispensing only
Non clinical pharmacists will dispense drugs to patients and usual care will be offered.
|
|
Experimental: Pharmaceutical care
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
asthma control of symptoms
Time Frame: 12 months
|
Measured by Asthma Control Questionnaire and medical evaluation
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 12 months
|
Measured by Asthma Quality of Life questionnaire
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function improvement
Time Frame: 12 months
|
Measured by spirometry
|
12 months
|
Quality of life improvement
Time Frame: 12 months
|
Measured by Asthma Quality of Life questionnaire
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pablo M Santos, Master, Federal University of Bahia
- Study Director: Álvaro A Cruz, Professor, Federal University of Bahia
- Study Chair: Lúcia B Noblat, Professor, Federal University of Bahia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATENFAR-PROAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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