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Completed

NCT Number: NCT01644357

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Quality of Life Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Salvador, Estado de Bahia, 40060-330, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. asthma control of symptoms

    Time frame: 12 months

    Measured by Asthma Control Questionnaire and medical evaluation

Other outcomes

  1. Lung function improvement

    Time frame: 12 months

    Measured by spirometry

  2. Quality of life improvement

    Time frame: 12 months

    Measured by Asthma Quality of Life questionnaire

Sponsors and collaborators

Lead sponsor

Federal University of Bahia

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
Jul 19, 2012
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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