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

Primary Purpose

Asthma, Inflammation, Patient Relations, Nurse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individualized educational program
Induced sputum collection
Spirometry
Nitric oxide measure
Questionnaires ACT, ACQ, AQLQ, BDI
Symptoms Diary
Peak flow measure
Exhaled breath condensate air measurement
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, inflammation, patients education, spirometry

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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
    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.
    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
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2018
    Last Updated
    September 3, 2018
    Sponsor
    University of Sao Paulo
    Collaborators
    Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo, Universidade Cidade de Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03655392
    Brief Title
    Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program
    Official Title
    Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    August 1, 2016 (Actual)
    Study Completion Date
    December 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo, Universidade Cidade de Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Objective: analyze clinical, functional and inflammatory features of adult patients with partly controlled and uncontrolled asthma, before and after an educational intervention. Methods: 58 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 in 3 visits with a one-month interval. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Inflammation, Patient Relations, Nurse, Spirometry
    Keywords
    asthma, inflammation, patients education, spirometry

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individualized educational program
    Other Intervention Name(s)
    Short term educational program
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Induced sputum collection
    Other Intervention Name(s)
    Induced sputum
    Intervention Description
    All participants performed induced sputum collection
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Spirometry
    Other Intervention Name(s)
    Lung function test
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Nitric oxide measure
    Other Intervention Name(s)
    NO measure
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaires ACT, ACQ, AQLQ, BDI
    Intervention Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Symptoms Diary
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Peak flow measure
    Other Intervention Name(s)
    Peak flow
    Intervention Description
    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).
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Exhaled breath condensate air measurement
    Other Intervention Name(s)
    EBC collection
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Induced sputum samples to assess airway inflammation
    Description
    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.
    Time Frame
    One day
    Title
    Pulmonary function by spirometry
    Description
    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
    Time Frame
    One day
    Title
    Asthma control by Asthma Control Test (ACT)
    Description
    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.
    Time Frame
    One day
    Title
    Depression symptoms by Beck Depression Inventory II (BDI II)
    Description
    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
    Time Frame
    One day
    Title
    Asthma quality of life by Asthma Quality of Life Questionnaire (AQLQ)
    Description
    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.
    Time Frame
    One day
    Title
    Fractional exhaled nitric oxide (FeNO)
    Description
    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.
    Time Frame
    One day
    Title
    Exhaled breath condensate (EBC)
    Description
    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.
    Time Frame
    One day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: 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 Exclusion criteria: Smokers Over 70 years old Airway infection Legally incapable persons Diseases that may affect respiratory function
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Soraia N Felix, Master
    Organizational Affiliation
    IAMPSE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34521963
    Citation
    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.
    Results Reference
    derived

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

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