NIV Application in the Treatment of Asthmatic Children

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939625
• Other study ID #: Rehabilitation in asthma
• Status: Completed
• Phase: N/A
• First received: October 12, 2016
• Last updated: October 19, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Spasm
• Child

Intervention

Device:
• muscle training

• Continue Positive Airway Pressure

• bilevel positive airway pressure

Locations

Country	Name	City	State
Brazil	Maisi David Cabral	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart Rate Variability		20 minutes
Secondary	manovacuometry		10 minutes
Secondary	Pulmonary function test		20 minutes
Secondary	bioelectrical impedance		10 minutes
Secondary	Bronchoconstriction induced by stress		30 minutes