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CompletedNCT02939625Updated Oct 23, 2017

NIV Application in the Treatment of Asthmatic Children

An interventional study of muscle training and Continue Positive Airway Pressure in Asthma, Child and Bronchial Spasm, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2017-10-23.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
5 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma
  • Child
  • Bronchial Spasm
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's enrollment of 68 is below the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Browse University of Nove de Julho studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 in the last 30 days;
  • not have presented respiratory infection in the last two months;
  • Signature of IC

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • 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

Interventions

  • Devicemuscle training
  • DeviceContinue Positive Airway Pressure
  • Devicebilevel positive airway pressure
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 minutes

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

07

Study locations

1 site
  • Maisi David Cabral
    São Paulo, 01504-001, Brazil
08

References and documents

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. PubMed 29865929 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2016
First posted
Oct 20, 2016
Start
Jan 2015
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Oct 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02939625
Lead sponsor
University of Nove de Julho
Responsible party
Daysi Tobelem (Md, University of Nove de Julho) — Principal investigator
First posted
Oct 20, 2016
Start date
Jan 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Oct 23, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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