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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644357
• Other study ID #: ATENFAR-PROAR
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: July 2014

Study information

• Verified date: September 2023
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Brazil	Program for Asthma Control (ProAR) of the Federal University of Bahia	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Bahia	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung function improvement	Measured by spirometry	12 months
Other	Quality of life improvement	Measured by Asthma Quality of Life questionnaire	12 months
Primary	asthma control of symptoms	Measured by Asthma Control Questionnaire and medical evaluation	12 months