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

NCT01644357 | Completed

• 1 other identifier: ATENFAR-PROAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Quality of Life

Outcome Measures

Primary Outcomes (1)

• asthma control of symptoms

  Measured by Asthma Control Questionnaire and medical evaluation

  12 months

Other Outcomes (2)

• Lung function improvement

  12 months

• Quality of life improvement

  12 months

Study Arms (2)

Dispensing only

NO INTERVENTION

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

Pharmaceutical care

EXPERIMENTAL

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

Interventions

Pharmaceutical care OTHER

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.

Pharmaceutical care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• participation in other intervention study during this study,
• living in other cities,
• could not participate in all visits of the study

Sponsors & Collaborators

• Federal University of Bahia: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

Salvador, Estado de Bahia, 40060-330, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pablo M Santos, Master

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• Álvaro A Cruz, Professor

  Federal University of Bahia

  STUDY DIRECTOR

• Lúcia B Noblat, Professor

  Federal University of Bahia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2014
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)