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

NCT03655392 | Completed

• 1 other identifier: IAMSPE
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

asthma; inflammation; patients education; spirometry

Outcome Measures

Primary Outcomes (7)

• Induced sputum samples to assess airway inflammation

  Induced sputum samples were collected in 3 visits with a one-month interval to assess the degree of airway inflammation. Markers of inflammation included eosinophils, neutrophils, macrophages, lymphocytes and total cell counts, as well as cytokines in the sputum supernatant. In the processing performed the subjects received up to three nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer (Ultraneb 99; DeVilbiss, Somerset, PA) each challenge was monitored with peak flow before, after and between nebulizations.

  One day

• Pulmonary function by spirometry

  Pulmonary function was assessed by spirometry pre and after bronchodilator (Salbutamol, short action beta-agonist), according to ATS guidelines, in 3 visits with a one-month interval after withholding short-acting beta-agonists for ≥ 6 hours and long-acting betaagonist for ≥ 24hours. Forced expiratory volume in one second (FEV1) % predicted was used as a proxy variable for overall lung function

  One day

• Asthma control by Asthma Control Test (ACT)

  Asthma Control Test (ACT) was used to assess clinical control of asthma in the last month; is a questionnaire composed of five questions (score varying from 5 to 25 points) assessing asthma in relation to physical activity limitation, nocturnal and diurnal symptoms, shortness of breath and use of rescue medication. The higher the overall score, the greater the asthma control, and a 3-point difference in the mean ACT score is considered a clinically relevant change.

  One day

• Depression symptoms by Beck Depression Inventory II (BDI II)

  To evaluate the symptoms of depression reported in the last 30 days, BDI II was used, a questionnaire composed of 21 items with scores ranging from 0 to 63 points, the higher the score the worse the severity of the symptoms

  One day

• Asthma quality of life by Asthma Quality of Life Questionnaire (AQLQ)

  Asthma quality of life was assessed using the AQLQ, which has four domains: activity limitations, symptoms, emotional function and environmental stimuli. A higher AQLQ score indicates a better quality of life.

  One day

• Fractional exhaled nitric oxide (FeNO)

  FeNO was collected also to assess airway inflammation in acoordance with the ATS recommendations; all measurements were determinad by chemiluminscence (Sievers 280). This analysis procedure was performed by a blinded investigator. The patients were advised to blow into a Mylar bag, with a breath pressure of 12 cmH20, monitored by the pressure gauge, reaching a flow rate of 200 mL/s.

  One day

• Exhaled breath condensate (EBC)

  A Turbo DECCS® condenser (Medivac SRL, Italy) (29) was used which was cooled to -20øC for at least thirty minutes prior to use. The subjects were instructed to perform oral breathing using the mouthpiece of the equipment and with the aid of a nasal clip. The EBC (exhaled breath condensate) was collected for 15 to 20 minutes in tidal volume for pH analysis and cytokine dosing.

  One day

Study Arms (2)

Intervention Group

EXPERIMENTAL

64 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (IG) (n=38) or control group (CG) (n=26). IG patients were submitted to a individualized educational program: three 30-minutes intervention of a shortterm educational program delivered by a nurse at 3 monthly visits. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, exhaled breath condensate air measurement, and answered the questionnaires ACT, ACQ, AQLQ, BDI: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI). All participants also answered a symptoms diary about asthma symptoms and peak flow measure.

Behavioral: Individualized educational program; Diagnostic Test: Induced sputum collection; Diagnostic Test: Spirometry; Diagnostic Test: Nitric oxide measure; Other: Questionnaires ACT, ACQ, AQLQ, BDI; Other: Symptoms Diary; Diagnostic Test: Peak flow measure; Diagnostic Test: Exhaled breath condensate air measurement

Control Group

EXPERIMENTAL

64 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (IG) (n=38) or control group (CG) (n=26). IG patients were submitted to three 30-minutes intervention of a shortterm educational program delivered by a nurse at 3 montly visits. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, exhaled breath condensate air measurement, and answered the questionnaires: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI). All participants also answered a symptoms diary about asthma symptoms and peak flow measure.

Diagnostic Test: Induced sputum collection; Diagnostic Test: Spirometry; Diagnostic Test: Nitric oxide measure; Other: Questionnaires ACT, ACQ, AQLQ, BDI; Other: Symptoms Diary; Diagnostic Test: Peak flow measure; Diagnostic Test: Exhaled breath condensate air measurement

Interventions

Individualized educational program BEHAVIORAL

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

Also known as: Short term educational program

Intervention Group

Induced sputum collection DIAGNOSTIC_TEST

All participants performed induced sputum collection

Also known as: Induced sputum

Control Group; Intervention Group

Spirometry DIAGNOSTIC_TEST

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.

Also known as: Lung function test

Control Group; Intervention Group

Nitric oxide measure DIAGNOSTIC_TEST

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.

Also known as: NO measure

Control Group; Intervention Group

Questionnaires ACT, ACQ, AQLQ, BDI OTHER

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)

Control Group; Intervention Group

Symptoms Diary OTHER

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

Control Group; Intervention Group

Peak flow measure DIAGNOSTIC_TEST

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).

Also known as: Peak flow

Control Group; Intervention Group

Exhaled breath condensate air measurement DIAGNOSTIC_TEST

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.

Also known as: EBC collection

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smokers or those who stopped smoking more than five years ago
• Age between 18-69 years
• Be legally capable
• Response to the short-acting bronchodilator FEV1\> 12% and\> 200 mL
• Absence of upper airway infection during 30 days and associated systemic diseases

You may not qualify if:

• Smokers
• Over 70 years old
• Airway infection
• Legally incapable persons
• Diseases that may affect respiratory function

Sponsors & Collaborators

• University of Sao Paulo: lead
• Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo: collaborator
• Universidade Cidade de Sao Paulo: collaborator

Related Publications (1)

• Felix SN, Agondi RC, Aun MV, Olivo CR, de Almeida FM, Amorim TS, Cezario JC, Giavina-Bianchi P, Tiberio IFLC, de Martins MA, Romanholo BMS. Clinical, functional and inflammatory evaluation in asthmatic patients after a simple short-term educational program: a randomized trial. Sci Rep. 2021 Sep 14;11(1):18267. doi: 10.1038/s41598-021-97846-8.

  PMID: 34521963 DERIVED

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

Spirometry; Respiratory Function Tests; Peak Expiratory Flow Rate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Forced Expiratory Flow Rates; Pulmonary Ventilation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Soraia N Felix, Master

  IAMPSE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 64 adult asthmatic patients (18-70 years old) were randomized into two groups: intervention group (IG) (n=38) or control group (CG) (n=26). IG patients were submitted to three 30-minutes intervention of a shortterm educational program delivered by a nurse at 3 mensal intervals. CG group did not receive educational intervention. All patients were submitted to a spirometry, induced sputum collection, nitric oxide measure, collecting exhaled condensed (cytokine analysis) air and it's ph measure, Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI), and answered a symptoms diary, Statistical analysis: repeated measures (Sigma Plot Software 3.0).

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: August 31, 2018
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 12, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share