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: Completed
• Conditions: Quality of Life; Asthma
• Intervention / Treatment: Other: Pharmaceutical care

• Study Type: Interventional
• Enrollment (Actual): 40
• 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

• Brazil
  • 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: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

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.	Other: Pharmaceutical care; 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	Measured by Asthma Control Questionnaire and medical evaluation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Measured by Asthma Quality of Life questionnaire	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function improvement	Measured by spirometry	12 months
Quality of life improvement	Measured by Asthma Quality of Life questionnaire	12 months

Collaborators and Investigators

• Sponsor: Federal University of Bahia
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• 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: August 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimated): July 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ATENFAR-PROAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publish a paper in a cientific journal