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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02939625
Enrollment
68
Registered
2016-10-20
Start date
2015-01-31
Completion date
2016-12-31
Last updated
2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchial Spasm, Child

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.

Interventions

DEVICEContinue Positive Airway Pressure

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Exhaled nitric oxide (part per billion)5 minutesassess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied

Secondary

MeasureTime frame
Heart Rate Variability20 minutes
manovacuometry10 minutes
Pulmonary function test20 minutes
bioelectrical impedance10 minutes
Bronchoconstriction induced by stress30 minutes

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026