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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01644357

Enrollment

Registered

2012-07-19

Start date

2008-08-31

Completion date

2014-07-31

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Quality of Life

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.

Interventions

OTHERPharmaceutical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
asthma control of symptoms	12 months	Measured by Asthma Control Questionnaire and medical evaluation

Other

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026