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Trial record 8 of 8 for:    Lavsan

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

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ClinicalTrials.gov Identifier: NCT03655392
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Universidade Cidade de Sao Paulo
Information provided by (Responsible Party):
Beatriz Mangueira Saraiva Romanholo, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Asthma Inflammation Patient Relations, Nurse Spirometry 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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Intervention Group
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
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
Other Name: Short term educational program

Diagnostic Test: Induced sputum collection
All participants performed induced sputum collection
Other Name: Induced sputum

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.
Other Name: Lung function test

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 Name: NO measure

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).
Other Name: Peak flow

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.
Other Name: EBC collection

Experimental: Control Group
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
All participants performed induced sputum collection
Other Name: Induced sputum

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.
Other Name: Lung function test

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 Name: NO measure

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).
Other Name: Peak flow

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.
Other Name: EBC collection




Primary Outcome Measures :
  1. Induced sputum samples to assess airway inflammation [ Time Frame: One day ]
    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.

  2. Pulmonary function by spirometry [ Time Frame: One day ]
    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

  3. Asthma control by Asthma Control Test (ACT) [ Time Frame: One day ]
    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.

  4. Depression symptoms by Beck Depression Inventory II (BDI II) [ Time Frame: One day ]
    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

  5. Asthma quality of life by Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: One day ]
    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.

  6. Fractional exhaled nitric oxide (FeNO) [ Time Frame: One day ]
    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.

  7. Exhaled breath condensate (EBC) [ Time Frame: One day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655392


Sponsors and Collaborators
University of Sao Paulo
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Soraia N Felix, Master IAMPSE

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Responsible Party: Beatriz Mangueira Saraiva Romanholo, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03655392     History of Changes
Other Study ID Numbers: IAMSPE
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beatriz Mangueira Saraiva Romanholo, University of Sao Paulo:
asthma
inflammation
patients education
spirometry
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents