AsthmaNCT03430505
Effects of Noninvasive Ventilation Compared to Salbutamol
A study testing Bilevel and Albuterol in people with Asthma, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Asthma is a chronic inflammatory disease characterized by recurrent and reversible episodes of airway obstruction. Drug treatment usually includes inhaled corticosteroids and bronchial dilators, which often do not have adequate adherence. Read more about this study
- Who is it for?
- Ages 12 to 29 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bilevel and Albuterol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2017to 20 Dec 2018
- 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 12 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12 to 29 years
- Both sexes
- Diagnosis of asthma according to GINA
- Without deterioration in the last 30 days
- No history of respiratory infection in the last 2 months
- Comply with consent form
Who cannot join
- Use bronchodilator under 12 hours
- No understanding of the tests
- Heart condition
- Intolerance the proposed activities
- Don't have bronchodilator prescribed by doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Noninvasive Ventilation Compared to Salbutamol in Respiratory Mechanics and Lung Function of Asthmatics After Bronchoprovocation: Randomized Cross-over Trial
Asthma is a chronic inflammatory disease characterized by recurrent and reversible episodes of airway obstruction. Drug treatment usually includes inhaled corticosteroids and bronchial dilators, which often do not have adequate adherence. These acute episodes of bronchoconstriction can most often occur with hyperinflation and for decades the mechanisms that lead to hyperinflation have been studied, as well as increasingly modern ways of evaluating and treating these mechanisms. Noninvasive ventilation is increasingly occupying its space as a non-pharmacological resource in the treatment of asthma, initially as an adjunct in an attempt to help medication have its effect reached in the crisis, but this feature has been showing signs of having an even greater action which can even collaborate in reversing the crisis by not only giving time for pharmacological action. Recognizing these potential effects of this widely used resource and understanding its action on lung function and the reversal of exacerbation is part of this scientific process.
Read the detailed description
Asthma is a chronic inflammatory disease characterized by recurrent episodes of reversible airway obstruction. The drug treatment typically includes inhaled steroids and bronco dilators. These acute episodes of bronchoconstriction can, for the most part, attend with hyperinflation, the hyperinflation and the consequent increase of functional residual capacity (FRC) inspiratory muscle activation in phase before the expiratory lung elastic equilibrium and rib cage.
Some studies reports the injury to respiratory function that causes acute hyperinflation with a reduction of the contribution of the abdominal compartment and increased assistance from the chest compartment, thereby reducing the efficiency mechanics of the diaphragm in response to decreased your stamping area. As a result of this disadvantage and mechanics "reduction of curvature" of the diaphragm expiratory muscle activation occurs in an attempt to restore the original mechanics and thus your primary function.
Some studies have investigated the effects of bronchoconstriction in recruitment of the respiratory muscles and respiratory mechanics of patients susceptible to asthma. As asthma has distinct characteristics in crisis and in stable phase, testing of bronchial provocation test have been part of the studies allowing assessment in different physiological conditions, close to an acute condition without necessarily a crisis and insufficiency that would make it really an assessment respiratory kinematics and the involvement of the thoracic and abdominal compartments in each of these phases and mainly in front of any therapy.
Bronchial provocation tests are safe once they cause the release of endogenous mediators that cause the bronchial smooth muscle contraction causing narrowing of the airway, but as your sensitivity is reduced your action is completely reversed with use of bronchodilator and the positive response to these tests that can be performed by exercise or inhaling hypertonic solution 4.5% reflect a inflammation of the Airways.
The interest in the implementation of non-pharmacological therapies and especially the knowledge of resources used often to relieve the overload of respiratory muscles in patients with obstructive, since the Decade of 80, has been demonstrating that the use of expiratory positive pressure can reduce muscle work and reduce the volume of expiratory reserve contributing to deflation.
Most recently the bronchodilator effect of CPAP mediated by autonomic receptors stretch lung. What we need to know is the effect of non-invasive ventilation with two levels of pressure can in addition to trigger this neural reflex, can still promote a kinematics similar to produced by bronchodilator seen through optoelectronics plethysmography (OEP).
The Optoelectronics Plethysmography (OEP) has made possible the exploitation of Thoracoabdominal movement by magazines, reporting especially changes in total volume of the chest wall during any intervention as the NIV.
The OEP is an innovative method of indirect measurement of pulmonary ventilation, and your application can be used in different health conditions, like asthma and neuromuscular diseases, with different protocols. Is a non-invasive method and measurement of non-ionizing lung volumes, able to detect small movements of the chest wall during breathing through the analysis of reflective markers attached to the chest wall of the individual; There is no need to use mouthpiece, nasal clip or other connector of the equipment to the individual; the calibration is fast and without the participation of the subject.
Since the NIV with bi-level pressure promotes a level of inspiratory pressure that increases the expiratory ventilation and a stretch of lung receptors stimulates and bronchodilator effect, the hypothesis of this study is that the thoracic and abdominal configuration and improvement of pulmonary function after test of bronchial provocation test is considerable with the NIV compared to bronchodilator. There are no studies in the literature that discuss this subject under this optics of assessment.
The aim of this study is to evaluate the effects of the NIV in reversal of bronchial provocation test and your potential bronchodilator effect compared to the gold standard bronchodilator drug seen by thoracic and abdominal and lung function configuration.
- General Purpose
To evaluate the responses of the thoracoabdominal configuration and the participation of the thoracic and abdominal compartments in asthmatic patients before the bronchoprovocation test and in response to pharmacological and non-pharmacological therapy.
2.1. Specific objectives
- To evaluate the abdominal thoracic configuration of adolescents and young adults with stable asthma before and after bronchoprovocation
- To evaluate the effect of bronchodilator and NIV in the thoraco-abdominal configuration
- Materials and Methods
3.1. Kind of study
This is a randomized, crossover clinical trial in which it will be performed in two visits and evaluated the abdominal thoracic configuration before and after bronchoprovocation and after bronchodilator and non-invasive ventilation (NIV) with two levels of pressure in adolescents and young adults with asthma.
3.2. Ethical aspects
This study will be developed respecting the research standards involving human beings (Resolution CNS 466/2012) of the National Health Council, was approved by the Research Ethics Committee of the University Nove de Julho (2.130.007 / 2017). You will have your registration done at clincaltrial.gov.
3.3. Place of study and sample
The study will be developed in the Multidisciplinary Laboratory of Movement, Optical Electronic Plethysmography (OEP) and in the Functional Respiratory Evaluation Laboratory located at the Latin American Memorial Campus of the University of Nove de Julho (UNINOVE), at Francisco Matarazzo Avenue, 376, Barra Funda , Sao Paulo-SP.
- Conditions
- Asthma
- Being tested
- Bilevel, Albuterol
- Keywords
- Asthma, noninvasive ventilation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilevelDevice
Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, IPAP 12 and EPAP 8 bilevel applied for 10 minutes, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.
AlbuterolDrug
Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, 400 micrograms inhaled Albuterol, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Bilevel | Active comparator | Bilevel 10 minutes after bronchoprovocation with saline solution 4.5%. IPAP 12 and EPAP 8 Receives: Device: Bilevel |
| Albuterol | Active comparator | 400micrograms after bronchoprovocation with saline solution 4.5%. Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Spirometry
Measured: Change from baseline FEV1 at 1 hour
Expiratory time
Optoeletronic Plethismography
Measured: Change from baseline expiratory time at 1 hour
Inspiratory Capacity
Spirometry
Measured: Change from baseline IC at 1 hour
Secondary outcomes (1)
Minute Volume
Optoeletronic Plethismography
Measured: Change from baseline minute volume at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start10 Jun 2017
- Primary completion11 Jul 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelim Leal de Freitas Dantas Gomes, PT, University of Nove de Julho
- Investigators
- Dirceu Costa, Doctor, Study chair, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430505
- Sponsor's protocol ID
- OEP Asthma
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noninvasive Ventilation Compared to Salbutamol in Respiratory Mechanics and Lung Function of Asthmatics After Bronchoprovocation: Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT03430505
- Acronym / sponsor ID
- OEP Asthma
- Conditions
- Asthma
- Keywords
- Asthma, noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 13 Feb 2018 (actual)
- 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 a chronic inflammatory disease characterized by recurrent and reversible episodes of airway obstruction. Drug treatment usually includes inhaled corticosteroids and bronchial dilators, which often do not have adequate adherence. These acute episodes of bronchoconstriction can most often occur with hyperinflation and for decades the mechanisms that lead to hyperinflation have been studied, as well as increasingly modern ways of evaluating and treating these mechanisms. Noninvasive ventilation is increasingly occupying its space as a non-pharmacological resource in the treatment of asthma, initially as an adjunct in an attempt to help medication have its effect reached in the crisis, but this feature has been showing signs of having an even greater action which can even collaborate in reversing the crisis by not only giving time for pharmacological action. Recognizing these potential effects of this widely used resource and understanding its action on lung function and the reversal of exacerbation is part of this scientific process.
Detailed description
Asthma is a chronic inflammatory disease characterized by recurrent episodes of reversible airway obstruction. The drug treatment typically includes inhaled steroids and bronco dilators. These acute episodes of bronchoconstriction can, for the most part, attend with hyperinflation, the hyperinflation and the consequent increase of functional residual capacity (FRC) inspiratory muscle activation in phase before the expiratory lung elastic equilibrium and rib cage.
Some studies reports the injury to respiratory function that causes acute hyperinflation with a reduction of the contribution of the abdominal compartment and increased assistance from the chest compartment, thereby reducing the efficiency mechanics of the diaphragm in response to decreased your stamping area. As a result of this disadvantage and mechanics "reduction of curvature" of the diaphragm expiratory muscle activation occurs in an attempt to restore the original mechanics and thus your primary function.
Some studies have investigated the effects of bronchoconstriction in recruitment of the respiratory muscles and respiratory mechanics of patients susceptible to asthma. As asthma has distinct characteristics in crisis and in stable phase, testing of bronchial provocation test have been part of the studies allowing assessment in different physiological conditions, close to an acute condition without necessarily a crisis and insufficiency that would make it really an assessment respiratory kinematics and the involvement of the thoracic and abdominal compartments in each of these phases and mainly in front of any therapy.
Bronchial provocation tests are safe once they cause the release of endogenous mediators that cause the bronchial smooth muscle contraction causing narrowing of the airway, but as your sensitivity is reduced your action is completely reversed with use of bronchodilator and the positive response to these tests that can be performed by exercise or inhaling hypertonic solution 4.5% reflect a inflammation of the Airways.
The interest in the implementation of non-pharmacological therapies and especially the knowledge of resources used often to relieve the overload of respiratory muscles in patients with obstructive, since the Decade of 80, has been demonstrating that the use of expiratory positive pressure can reduce muscle work and reduce the volume of expiratory reserve contributing to deflation.
Most recently the bronchodilator effect of CPAP mediated by autonomic receptors stretch lung. What we need to know is the effect of non-invasive ventilation with two levels of pressure can in addition to trigger this neural reflex, can still promote a kinematics similar to produced by bronchodilator seen through optoelectronics plethysmography (OEP).
The Optoelectronics Plethysmography (OEP) has made possible the exploitation of Thoracoabdominal movement by magazines, reporting especially changes in total volume of the chest wall during any intervention as the NIV.
The OEP is an innovative method of indirect measurement of pulmonary ventilation, and your application can be used in different health conditions, like asthma and neuromuscular diseases, with different protocols. Is a non-invasive method and measurement of non-ionizing lung volumes, able to detect small movements of the chest wall during breathing through the analysis of reflective markers attached to the chest wall of the individual; There is no need to use mouthpiece, nasal clip or other connector of the equipment to the individual; the calibration is fast and without the participation of the subject.
Since the NIV with bi-level pressure promotes a level of inspiratory pressure that increases the expiratory ventilation and a stretch of lung receptors stimulates and bronchodilator effect, the hypothesis of this study is that the thoracic and abdominal configuration and improvement of pulmonary function after test of bronchial provocation test is considerable with the NIV compared to bronchodilator. There are no studies in the literature that discuss this subject under this optics of assessment.
The aim of this study is to evaluate the effects of the NIV in reversal of bronchial provocation test and your potential bronchodilator effect compared to the gold standard bronchodilator drug seen by thoracic and abdominal and lung function configuration.
- General Purpose
To evaluate the responses of the thoracoabdominal configuration and the participation of the thoracic and abdominal compartments in asthmatic patients before the bronchoprovocation test and in response to pharmacological and non-pharmacological therapy.
2.1. Specific objectives
- To evaluate the abdominal thoracic configuration of adolescents and young adults with stable asthma before and after bronchoprovocation
- To evaluate the effect of bronchodilator and NIV in the thoraco-abdominal configuration
- Materials and Methods
3.1. Kind of study
This is a randomized, crossover clinical trial in which it will be performed in two visits and evaluated the abdominal thoracic configuration before and after bronchoprovocation and after bronchodilator and non-invasive ventilation (NIV) with two levels of pressure in adolescents and young adults with asthma.
3.2. Ethical aspects
This study will be developed respecting the research standards involving human beings (Resolution CNS 466/2012) of the National Health Council, was approved by the Research Ethics Committee of the University Nove de Julho (2.130.007 / 2017). You will have your registration done at clincaltrial.gov.
3.3. Place of study and sample
The study will be developed in the Multidisciplinary Laboratory of Movement, Optical Electronic Plethysmography (OEP) and in the Functional Respiratory Evaluation Laboratory located at the Latin American Memorial Campus of the University of Nove de Julho (UNINOVE), at Francisco Matarazzo Avenue, 376, Barra Funda , Sao Paulo-SP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilevel | Active comparator | Device: BilevelBilevel 10 minutes after bronchoprovocation with saline solution 4.5%. IPAP 12 and EPAP 8 |
| Albuterol | Active comparator | Drug: Albuterol400micrograms after bronchoprovocation with saline solution 4.5%. |
Who may qualify
- Ages
- 12 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 12 to 29 years
- Both sexes
- Diagnosis of asthma according to GINA
- Without deterioration in the last 30 days
- No history of respiratory infection in the last 2 months
Key exclusion criteria (5 listed)
- Use bronchodilator under 12 hours
- No understanding of the tests
- Heart condition
- Intolerance the proposed activities
- Don't have bronchodilator prescribed by doctor
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 |
|---|---|---|
| BilevelBasal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, IPAP 12 and EPAP 8 bilevel applied for 10 minutes, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour. | Device | Bilevel |
| AlbuterolBasal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, 400 micrograms inhaled Albuterol, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour. | Drug | Albuterol |
Primary outcome
FEV1
Time frame: Change from baseline FEV1 at 1 hour
Spirometry
Expiratory time
Time frame: Change from baseline expiratory time at 1 hour
Optoeletronic Plethismography
Inspiratory Capacity
Time frame: Change from baseline IC at 1 hour
Spirometry
1 secondary outcome
Minute Volume
Time frame: Change from baseline minute volume at 1 hour
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 22 Jul 2019.
- 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.
Dirceu Costa, Doctor study chair
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel and Albuterol in people with Asthma, 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 6 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 22 Jul 2019. 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?
FEV1 (time frame: Change from baseline FEV1 at 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2019.