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

Primary Purpose

Asthma, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pharmaceutical care
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Program for Asthma Control (ProAR) of the Federal University of Bahia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Dispensing only

Pharmaceutical care

Arm Description

Non clinical pharmacists will dispense drugs to patients and usual care will be offered.

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.

Outcomes

Primary Outcome Measures

asthma control of symptoms
Measured by Asthma Control Questionnaire and medical evaluation

Secondary Outcome Measures

Full Information

First Posted
July 17, 2012
Last Updated
September 11, 2023
Sponsor
Federal University of Bahia
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01644357
Brief Title
Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma
Official Title
Effect of a 12-month Pharmaceutical Care Program on Severe Asthma Patient. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dispensing only
Arm Type
No Intervention
Arm Description
Non clinical pharmacists will dispense drugs to patients and usual care will be offered.
Arm Title
Pharmaceutical care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmaceutical care
Intervention Description
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.
Primary Outcome Measure Information:
Title
asthma control of symptoms
Description
Measured by Asthma Control Questionnaire and medical evaluation
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Lung function improvement
Description
Measured by spirometry
Time Frame
12 months
Title
Quality of life improvement
Description
Measured by Asthma Quality of Life questionnaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo M Santos, Master
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Álvaro A Cruz, Professor
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lúcia B Noblat, Professor
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Chair
Facility Information:
Facility Name
Program for Asthma Control (ProAR) of the Federal University of Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40060-330
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Publish a paper in a cientific journal

Learn more about this trial

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

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