NCT02939625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

October 12, 2016

Last Update Submit

October 19, 2017

Conditions

AsthmaChildBronchial Spasm

Outcome Measures

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

    5 minutes

Secondary Outcomes (5)

  • Heart Rate Variability

    20 minutes

  • manovacuometry

    10 minutes

  • Pulmonary function test

    20 minutes

  • bioelectrical impedance

    10 minutes

  • Bronchoconstriction induced by stress

    30 minutes

Study Arms (3)

muscle training

ACTIVE COMPARATOR

participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions

Device: muscle trainingDevice: Continue Positive Airway PressureDevice: bilevel positive airway pressure

bilevel positive airway pressure

ACTIVE COMPARATOR

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 trainingDevice: Continue Positive Airway PressureDevice: bilevel positive airway pressure

Continue Positive Airway Pressure

ACTIVE COMPARATOR

participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions

Device: muscle trainingDevice: Continue Positive Airway PressureDevice: bilevel positive airway pressure

Interventions

muscle trainingDEVICE
Continue Positive Airway Pressurebilevel positive airway pressuremuscle training
Continue Positive Airway PressureDEVICE
Continue Positive Airway Pressurebilevel positive airway pressuremuscle training
bilevel positive airway pressureDEVICE
Continue Positive Airway Pressurebilevel positive airway pressuremuscle training

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisi David Cabral

São Paulo, 01504-001, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 29865929DERIVED

MeSH Terms

Conditions

AsthmaBronchial Spasm

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 20, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 23, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)