AsthmaNCT02939625
NIV Application in the Treatment of Asthmatic Children
A study testing muscle training, Continue Positive Airway Pressure and bilevel positive airway pressure in people with Asthma and Child, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma, Child, Bronchial Spasm
- What is being tested?
- muscle training, Continue Positive Airway Pressure and bilevel positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
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.
- Conditions
- Asthma, Child, Bronchial Spasm
- Being tested
- muscle training, Continue Positive Airway Pressure, bilevel positive airway pressure
- Medical subject headings
- Asthma, Bronchial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle trainingDevice
Continue Positive Airway PressureDevice
bilevel positive airway pressureDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: muscle training; Device: Continue Positive Airway Pressure; Device: 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 Receives: Device: muscle training; Device: Continue Positive Airway Pressure; Device: 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 Receives: Device: muscle training; Device: Continue Positive Airway Pressure; Device: bilevel positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Secondary outcomes (5)
Heart Rate Variability
Measured: 20 minutes
manovacuometry
Measured: 10 minutes
Pulmonary function test
Measured: 20 minutes
bioelectrical impedance
Measured: 10 minutes
Bronchoconstriction induced by stress
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daysi Tobelem, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939625
- Sponsor's protocol ID
- Rehabilitation in asthma
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2016
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
- ClinicalTrials.gov ID
- NCT02939625
- Acronym / sponsor ID
- Rehabilitation in asthma
- Conditions
- Asthma, Child, Bronchial Spasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| muscle training | Active comparator | Device: muscle training, Device: Continue Positive Airway Pressure, Device: bilevel positive airway pressureparticipants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions |
| bilevel positive airway pressure | Active comparator | Device: muscle training, Device: Continue Positive Airway Pressure, Device: bilevel positive airway pressureparticipants 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 |
| Continue Positive Airway Pressure | Active comparator | Device: muscle training, Device: Continue Positive Airway Pressure, Device: bilevel positive airway pressureparticipants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle training | Device | Continue Positive Airway Pressure, bilevel positive airway pressure, muscle training |
| Continue Positive Airway Pressure | Device | Continue Positive Airway Pressure, bilevel positive airway pressure, muscle training |
| bilevel positive airway pressure | Device | Continue Positive Airway Pressure, bilevel positive airway pressure, muscle training |
Primary outcome
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
5 secondary outcomes
Heart Rate Variability
Time frame: 20 minutes
manovacuometry
Time frame: 10 minutes
Pulmonary function test
Time frame: 20 minutes
bioelectrical impedance
Time frame: 10 minutes
Bronchoconstriction induced by stress
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Derived from this study: PubMed 29865929David 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle training, Continue Positive Airway Pressure and bilevel positive airway pressure in people with Asthma and Child, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled nitric oxide (part per billion) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.