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NIV Application in the Treatment of Asthmatic Children

Primary Purpose

Asthma, Child, Bronchial Spasm

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
muscle training
Continue Positive Airway Pressure
bilevel positive airway pressure
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 5:11 years;
  • Both sexes;
  • Do not be included in any regular physical activity program;
  • Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA);
  • Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days;
  • not have presented respiratory infection in the last two months;
  • Signature of IC

Exclusion Criteria:

  • Have done inhaled bronchodilator in less than 12 hours before the assessment;
  • Inability to understand or perform any of the tests, due to physical and mental limitations;
  • Intolerance proposed activities;
  • Have heart disease inflammatory, congenital or ischemic origin;
  • Being in the presence of any infectious process with fever.

Sites / Locations

  • Maisi David Cabral

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

muscle training

bilevel positive airway pressure

Continue Positive Airway Pressure

Arm Description

participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions

participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions

participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions

Outcomes

Primary Outcome Measures

Exhaled nitric oxide (part per billion)
assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied

Secondary Outcome Measures

Heart Rate Variability
manovacuometry
Pulmonary function test
bioelectrical impedance
Bronchoconstriction induced by stress

Full Information

First Posted
October 12, 2016
Last Updated
October 19, 2017
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02939625
Brief Title
NIV Application in the Treatment of Asthmatic Children
Official Title
Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.
Detailed Description
Pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately. There is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the BIE.The aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the BIE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Child, Bronchial Spasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
muscle training
Arm Type
Active Comparator
Arm Description
participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
Arm Title
bilevel positive airway pressure
Arm Type
Active Comparator
Arm Description
participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions
Arm Title
Continue Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
Intervention Type
Device
Intervention Name(s)
muscle training
Intervention Type
Device
Intervention Name(s)
Continue Positive Airway Pressure
Intervention Type
Device
Intervention Name(s)
bilevel positive airway pressure
Primary Outcome Measure Information:
Title
Exhaled nitric oxide (part per billion)
Description
assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Time Frame
20 minutes
Title
manovacuometry
Time Frame
10 minutes
Title
Pulmonary function test
Time Frame
20 minutes
Title
bioelectrical impedance
Time Frame
10 minutes
Title
Bronchoconstriction induced by stress
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 5:11 years; Both sexes; Do not be included in any regular physical activity program; Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA); Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days; not have presented respiratory infection in the last two months; Signature of IC Exclusion Criteria: Have done inhaled bronchodilator in less than 12 hours before the assessment; Inability to understand or perform any of the tests, due to physical and mental limitations; Intolerance proposed activities; Have heart disease inflammatory, congenital or ischemic origin; Being in the presence of any infectious process with fever.
Facility Information:
Facility Name
Maisi David Cabral
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29865929
Citation
David MMC, Gomes ELFD, Mello MC, Costa D. Noninvasive ventilation and respiratory physical therapy reduce exercise-induced bronchospasm and pulmonary inflammation in children with asthma: randomized clinical trial. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618777723. doi: 10.1177/1753466618777723.
Results Reference
derived

Learn more about this trial

NIV Application in the Treatment of Asthmatic Children

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