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OpenTrials
Completed

NCT Number: NCT02939625

NIV Application in the Treatment of Asthmatic Children

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.

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Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisi David Cabral

São Paulo, 01504-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

muscle training

Device

Continue Positive Airway Pressure

Device

Bilevel Positive Airway Pressure

Device

Primary outcomes

  1. Exhaled nitric oxide (part per billion)

    Time frame: 5 minutes

    assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied

Secondary outcomes

  1. Heart Rate Variability

    Time frame: 20 minutes

  2. manovacuometry

    Time frame: 10 minutes

  3. Pulmonary function test

    Time frame: 20 minutes

  4. bioelectrical impedance

    Time frame: 10 minutes

  5. Bronchoconstriction induced by stress

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2016
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.