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NIV Application in the Treatment of Asthmatic Children

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ClinicalTrials.gov Identifier: NCT02939625
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Daysi Tobelem, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Asthma Child Bronchial Spasm Device: muscle training Device: Continue Positive Airway Pressure Device: bilevel positive airway pressure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939625


Locations
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Brazil
Maisi David Cabral
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daysi Tobelem, Md, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02939625     History of Changes
Other Study ID Numbers: Rehabilitation in asthma
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases