Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program

Summary

Background: Patient education is one of the pillars of asthma treatment according to GINA guidelines. It has considered essential for adherence to treatment and for correct technique of inhaled devices.

Conditions

• Asthma
• Inflammation
• Patient Relations, Nurse
• Spirometry

Interventions

BEHAVIORAL

Individualized educational program

IG patients were submitted to three 30-minutes intervention of a individualized shortterm educational program delivered by a nurse, were given explanations about general aspects of the disease, prevention methods and about the importance and correct use of inhaled corticosteroids, with an educational video showing the use of the device

DIAGNOSTIC_TEST

Induced sputum collection

All participants performed induced sputum collection

DIAGNOSTIC_TEST

Spirometry

All participants performed spirometry test using a Koko spirometer. Pulmonary function was assessed by spirometry prebronchodilator, after withholding short-acting beta-agonists for ≥ 6 hours and long-acting beta-agonist for ≥ 24hours. Forced expiratory volume in one second (FEV1) % predicted was used as a proxy variable for overall lung function.

DIAGNOSTIC_TEST

Nitric oxide measure

All participants performed nitric oxide measure in three Mylar bags and measure was performed in a NOA280 Sievers equipment. For collection the patients blew in the balloons through a sterile nozzle in the equipment collector without prejudice or damage to the patient.

OTHER

Questionnaires ACT, ACQ, AQLQ, BDI

All participants answered standardized questionnaires about asthma symptoms and depression: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI)

OTHER

Symptoms Diary

All participants were instructed to note in the morning and evening before the use of routine inhaled corticosteroids, asthma symptoms (coughing, wheezing, shortness of breath, use of emergency inhaled corticosteroids) and three measures of peak expiratory flow (individual, provided to patients) and to return this completed diary at each study visit

DIAGNOSTIC_TEST

Peak flow measure

All participants registered three peak flow measures in the symptoms diary by morning and night before the use of routine inhaled corticosteroids. Peak flow was measured by the electronic peak flow meter (Mini-Wright).

DIAGNOSTIC_TEST

Exhaled breath condensate air measurement

Exhaled breath condensate was collect during 15 to 20 minutes in a Turbo DECCS equipment (Medivac SRL, Italy) in a sterile buccal of the own apparatus with the aid of a nasal clip with the participant breathing normally without any effort or damage.

Sponsors & Collaborators

• Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

  collaborator OTHER

• Universidade Cidade de Sao Paulo

  collaborator OTHER

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Soraia N Felix, Master · IAMPSE

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-01

Primary Completion

2016-08-01

Completion

2017-12-12