NIV Application in the Treatment of Asthmatic Children

Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized

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.

Study Overview

• Status: Completed
• Conditions: Child; Asthma; Bronchial Spasm
• Intervention / Treatment: Device: muscle training; Device: Continue Positive Airway Pressure; Device: bilevel positive airway pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Maisi David Cabral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: muscle training; participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions	Device: muscle training; Device: Continue Positive Airway Pressure; Device: bilevel positive airway pressure
Active Comparator: bilevel positive airway pressure; 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	Device: muscle training; Device: Continue Positive Airway Pressure; Device: bilevel positive airway pressure
Active Comparator: Continue Positive Airway Pressure; participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions	Device: muscle training; Device: Continue Positive Airway Pressure; Device: bilevel positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart Rate Variability	20 minutes
manovacuometry	10 minutes
Pulmonary function test	20 minutes
bioelectrical impedance	10 minutes
Bronchoconstriction induced by stress	30 minutes

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchial Spasm
• Other Study ID Numbers: Rehabilitation in asthma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO