COPDNCT03271905
Influence of Mechanical Ventilation Modes on the Efficacy of Nebulized Bronchodilator
A study testing salbutamol sulfate and ipratropium bromide and Mesh nebulization in people with COPD and Asthma, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Aerosol therapy is widely used in intensive care in critically ill patients that use mechanical ventilation (MV). However, there is a lack of standardization about aerosol performance in this group of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- salbutamol sulfate and ipratropium bromide and Mesh nebulization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2017to 10 Dec 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with asthma or chronic obstructive pulmonary disease (COPD) Invasive mechanical ventilation Hemodynamically stable
Who cannot join
- Prescribed metered dose inhaler (MDI) or intravenous bronchodilators Undrained pneumothorax Bronchopleural fistula Chest trauma Tracheoesophageal fistula Tracheal granulomas Tracheal stenosis PEEP dependence
- Contraindicated disconnection of the MV
- Endotracheal tube diameter less than 7.5
- Do not make part of the protocol of daily sedation
- No regular ventilatory drive when with out sedation
- Do not reach a minimum tidal volume 6 ml/kg with a maximum peak pressure (PIP) of 35 cmH2O (centimeter of water) during MV.
- Do not use the same MV modes that will be tested in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Mechanical Ventilation Modes on the Efficacy of Nebulized Bronchodilator in the Treatment of Patients With Obstructive Pulmonary Disease
Aerosol therapy is widely used in intensive care in critically ill patients that use mechanical ventilation (MV). However, there is a lack of standardization about aerosol performance in this group of patients. Thus, this study aims to evaluate the effect of nebulization performed in different ventilatory modes on lung function and regional pulmonary distribution of critical patients with chronic obstructive pulmonary disease. It is a clinical trial, crossover, randomized, controlled and blind. Three interventions with bronchodilators will be performed: in the Pressure Controlled Ventilation mode (PCV) with positive end expiratory pressure (PEEP) = 85% of autoPEEP, in the PCV mode with PEEP = 15 cmH2Oand in the Pressure Support Mode (PSV). Pulmonary function data will be evaluated through Electrical Impedance Tomography to evaluate the efficacy of the bronchodilator in different ventilatory modes.
Read the detailed description
- OBJECTIVES
2.1 Primary
- To evaluate the influence of mechanical ventilation modes in the efficacy of nebulized bronchodilator in ventilator dependent patients with obstructive pulmonary disease.
2.2 Secondary
- To compare regional ventilation distribution through Ventilation Surface Area (VSA) and Tidal Impedance Variation (TIV or ∆Z) by electrical impedance tomography (EIT) before, immediately after, after 1hour (h), 2h and 3h of nebulized bronchodilator in pressure controlled ventilation (PCV) with and without sedative drugs, and during pressure support ventilation (PSV).
- To compare the peak expiratory flow (PEF), change in End-Expiratory Lung Volume (dEELV), Respiratory Compliance (Crs) and Resistance (R), before, immediately after, after 1h, 2h and 3h of nebulized bronchodilator by monitoring airway pressure and EIT in ventilator modes PCV, with and without sedative drugs and PSV .
- To compare the ventilator modes on the VSA, ∆Z, PEF, dEELV and Crs after nebulized bronchodilator and the duration of its effects during mechanical ventilation.
- To compare two different level of PEEP during nebulized bronchodilator on PCV mode while the patient stay with sedative drugs.
- METHODS
3.1 Study design This is a randomized crossover, blinded clinical trial. The randomization procedure will be a simple randomization by random number table. In order to improve reliability, not transparent sealed envelopes for blind allocation will be used.
3.2 Local and study period This is a multicenter study that involve the following hospitals: Hospital Miguel Arraes - PE and Real Hospital Português de Beneficência em Pernambuco- PE. All hospitals are located in the metropolitan region of Recife, Pernambuco, Brazil and the study will be conducted from February 2016 to December 2019.
3.3 Sample The study population consist of patients with obstructive pulmonary disease admitted to intensive care unit for MV support who meet the inclusion criteria.
3.4 Sample size Patients will be identified by a daily telephone calls to the ICUs each morning for data collection. Potential candidate patients will be screened for inclusion and exclusinon criteria, after the identification of eligible patients. After consent is obtained, the research team goes to the ICU to start collecting data. The sample size will be calculated by statistical procedures after conducting a pilot study of 10 patients.
3.5 Technical procedures and tools for data collection
Prior to starting the intervention, clinical and demographic data will be collected according to the evaluation form, ( Appendix 2). After that, patients will be receive each of 4 interventions, with a minimum of 4 hours between bronchodilator administration to allow for washout.
3.5.1. Intervention Protocol 3.5.1.1. Step 1: Nebulization during Pressure Controlled Ventilation (PCV) Mode Initially the patient will be accessed when he still sedated. Two intervention will be done with a PCV mode in two different ways and the order of the procedures will be randomized.
One nebulization will be done with a standard PCV mode and parameters will be setted as follows: sufficient Δ pressure to maintain the patient's tidal volume (vt) at 6 / kg ideal weight, respiratory rate (RR) at 12 bpm, inspiratory time (Ti) up to 1 second, maintain Ti / Ttot 0.3 - 0.4 without causing dynamic AutoPEEP, decreasing waveform flow and PEEP level of 85% from static autoPEEP.
Other nebulization will be done also in PCV mode with same parameters, but the level of PEEP will be increased to 15 cmH2O. Between this two interventions will be given 4 hours for washout.
After this, we will talk to the medical staff to interrupt sedation, will be given 3 hour for wash out to start de Step 2.
3.5.1.2. Step 2: Nebulization During Pressure Support Ventilation (PSV) With a clinical progression of the patient, a 4th evaluation will be done on the first day when the patient achieve PSV mode. In this ventilation mode the patient will control the Ti, Ttot, RR and inspiratory flow so it will be set only one Δ pressure for the patient to support a Vt of 6 ml/kg. The lowest minimum value of Δ P is 10 cmH2O and the end of inspiratory phase will be determined by a decrease at 25% of the patient peak inspiratory flow.
3.5.2 Nebulization Protocol
Nebulized bronchodilator drugs will be Salbutamol Sulfate (aerolin nebulis) and ipratropium bromide (atrovent) diluted in a saline solution (saline 0.9%) in 3 ml. The vibrating Mesh nebulizer (Aeroneb Pro-X, Galway, Ireland) will be placed in the inspiratory circuit of the MV immediately before 'Y' piece using a 22 mm T adapter. The nebulizer is operated by an electric controller connected mains power. The vibrating Mesh produces aerosol with an average particle size of 5 μm and will remain on continuously until the end of nebulization.
If a heat moisture exchanger (HME) is used during mechanical ventilation, it must be removed from between the nebulizer and airway before nebulization so that it does not filter out and reduce aerosol delivered.
3.5.3 Evaluation by Electrical Impedance Tomography. TIE is a tool of obtaining transverse plane image of any section of the human body by means of low-power electric current. The image is obtained from the electric current or potential detected on the surface of the evaluated area, where each "pixel" image is its impedance or resistivity. Thus, when used in thoracic follow-up, the EIT is able to evaluate the aeration and ventilation of the patient through the following variables: distribution of regional lung ventilation by Tidal Impedance Variation (ΔZ), Ventilation Surface Area (VSA), Percentage of Recruitable Lung (PRLV), Change in End-Expiratory Lung Volume (dEELV) and Respiratory Compliance (Crs) .
Initially, to evaluate the acute pulmonary impact of nebulizer bronchodilator on different ventilatory modes, EIT will be be performed before and immediately after the aerosol administration and repeated with each ventilation mode. Furthermore, the duration of nebulization effect will be evaluated by performing EIT after 1, 2 and 3h in each ventilation mode. There will be a > 4 hour washout between bronchodilator administrations.
An impedance tomography (ENLIGHTER, Timpel, Brazil) will be used with the patient in supine position with a bed elevation of 45◦, so a belt with 32 electrodes will be applied to the chest, in the position corresponding to the 4th - 5th intercostal space on a shaved skin. Electrodes have to be positioned for reading electrocardiograms and a flow sensor that should be attached to the endotracheal tube. After this procedures recording data starts for 3 minutes.
For image acquisition, harmless electrical currents (5-8 nA, 125 KHz) will be injectates through electrode pairs in rotating sequence, and the potential differences Will be captured in other non injetantes electrode. Variations in thoracic impedance will be evaluated through a LabView software (National Instruments, USA) and the data is recorded in separate files for patients for further analysis.
- Being tested
- salbutamol sulfate and ipratropium bromide, Mesh nebulization
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamol sulfate and ipratropium bromideDrug
Nebulization with salbutamol sulfate and ipratropium bromide during mechanical ventilation.
Mesh nebulizationDevice
Nebulization with Mesh device.
| Study group | Role | What they receive |
|---|---|---|
| Pressure-controled-ventilation (PCV) | Experimental | Nebulization during mechanical ventilation on a pressure controled ventilation mode. Receives: Drug: salbutamol sulfate and ipratropium bromide; Device: Mesh nebulization |
| PCV and high PEEP | Experimental | Nebulization during mechanical ventilation on a pressure controled ventilation mode and PEEP = 15 cmH2O. Receives: Drug: salbutamol sulfate and ipratropium bromide; Device: Mesh nebulization |
| Pressure suport ventilation (PSV) | Experimental | Nebulization during mechanical ventilation on a pressure suport ventilation mode. Receives: Drug: salbutamol sulfate and ipratropium bromide; Device: Mesh nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tidal Impedance Variation
compare regional ventilation distribution by electrical impedance tomography
Measured: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Secondary outcomes (3)
Change in compliance of respiratory sistem (cmH2O)
Compare results evaluated by lung mechanics evaluation
Measured: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Change in peak expiratory flow (lpm)
Compare results evaluated by EIT
Measured: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Change in End-Expiratory Lung Volume
Compare results evaluated by EIT
Measured: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start10 Apr 2017
- Primary completion10 Dec 2018
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cibelle Andrade Lima, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271905
- Sponsor's protocol ID
- CibelleAndrade
- Status last verified
- May 2019
- First submitted
- 8 Jun 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mechanical Ventilation Modes on the Efficacy of Nebulized Bronchodilator in the Treatment of Patients With Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03271905
- Acronym / sponsor ID
- CibelleAndrade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 5 Sep 2017 (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.
Aerosol therapy is widely used in intensive care in critically ill patients that use mechanical ventilation (MV). However, there is a lack of standardization about aerosol performance in this group of patients. Thus, this study aims to evaluate the effect of nebulization performed in different ventilatory modes on lung function and regional pulmonary distribution of critical patients with chronic obstructive pulmonary disease. It is a clinical trial, crossover, randomized, controlled and blind. Three interventions with bronchodilators will be performed: in the Pressure Controlled Ventilation mode (PCV) with positive end expiratory pressure (PEEP) = 85% of autoPEEP, in the PCV mode with PEEP = 15 cmH2Oand in the Pressure Support Mode (PSV). Pulmonary function data will be evaluated through Electrical Impedance Tomography to evaluate the efficacy of the bronchodilator in different ventilatory modes.
Detailed description
- OBJECTIVES
2.1 Primary
- To evaluate the influence of mechanical ventilation modes in the efficacy of nebulized bronchodilator in ventilator dependent patients with obstructive pulmonary disease.
2.2 Secondary
- To compare regional ventilation distribution through Ventilation Surface Area (VSA) and Tidal Impedance Variation (TIV or ∆Z) by electrical impedance tomography (EIT) before, immediately after, after 1hour (h), 2h and 3h of nebulized bronchodilator in pressure controlled ventilation (PCV) with and without sedative drugs, and during pressure support ventilation (PSV).
- To compare the peak expiratory flow (PEF), change in End-Expiratory Lung Volume (dEELV), Respiratory Compliance (Crs) and Resistance (R), before, immediately after, after 1h, 2h and 3h of nebulized bronchodilator by monitoring airway pressure and EIT in ventilator modes PCV, with and without sedative drugs and PSV .
- To compare the ventilator modes on the VSA, ∆Z, PEF, dEELV and Crs after nebulized bronchodilator and the duration of its effects during mechanical ventilation.
- To compare two different level of PEEP during nebulized bronchodilator on PCV mode while the patient stay with sedative drugs.
- METHODS
3.1 Study design This is a randomized crossover, blinded clinical trial. The randomization procedure will be a simple randomization by random number table. In order to improve reliability, not transparent sealed envelopes for blind allocation will be used.
3.2 Local and study period This is a multicenter study that involve the following hospitals: Hospital Miguel Arraes - PE and Real Hospital Português de Beneficência em Pernambuco- PE. All hospitals are located in the metropolitan region of Recife, Pernambuco, Brazil and the study will be conducted from February 2016 to December 2019.
3.3 Sample The study population consist of patients with obstructive pulmonary disease admitted to intensive care unit for MV support who meet the inclusion criteria.
3.4 Sample size Patients will be identified by a daily telephone calls to the ICUs each morning for data collection. Potential candidate patients will be screened for inclusion and exclusinon criteria, after the identification of eligible patients. After consent is obtained, the research team goes to the ICU to start collecting data. The sample size will be calculated by statistical procedures after conducting a pilot study of 10 patients.
3.5 Technical procedures and tools for data collection
Prior to starting the intervention, clinical and demographic data will be collected according to the evaluation form, ( Appendix 2). After that, patients will be receive each of 4 interventions, with a minimum of 4 hours between bronchodilator administration to allow for washout.
3.5.1. Intervention Protocol 3.5.1.1. Step 1: Nebulization during Pressure Controlled Ventilation (PCV) Mode Initially the patient will be accessed when he still sedated. Two intervention will be done with a PCV mode in two different ways and the order of the procedures will be randomized.
One nebulization will be done with a standard PCV mode and parameters will be setted as follows: sufficient Δ pressure to maintain the patient's tidal volume (vt) at 6 / kg ideal weight, respiratory rate (RR) at 12 bpm, inspiratory time (Ti) up to 1 second, maintain Ti / Ttot 0.3 - 0.4 without causing dynamic AutoPEEP, decreasing waveform flow and PEEP level of 85% from static autoPEEP.
Other nebulization will be done also in PCV mode with same parameters, but the level of PEEP will be increased to 15 cmH2O. Between this two interventions will be given 4 hours for washout.
After this, we will talk to the medical staff to interrupt sedation, will be given 3 hour for wash out to start de Step 2.
3.5.1.2. Step 2: Nebulization During Pressure Support Ventilation (PSV) With a clinical progression of the patient, a 4th evaluation will be done on the first day when the patient achieve PSV mode. In this ventilation mode the patient will control the Ti, Ttot, RR and inspiratory flow so it will be set only one Δ pressure for the patient to support a Vt of 6 ml/kg. The lowest minimum value of Δ P is 10 cmH2O and the end of inspiratory phase will be determined by a decrease at 25% of the patient peak inspiratory flow.
3.5.2 Nebulization Protocol
Nebulized bronchodilator drugs will be Salbutamol Sulfate (aerolin nebulis) and ipratropium bromide (atrovent) diluted in a saline solution (saline 0.9%) in 3 ml. The vibrating Mesh nebulizer (Aeroneb Pro-X, Galway, Ireland) will be placed in the inspiratory circuit of the MV immediately before 'Y' piece using a 22 mm T adapter. The nebulizer is operated by an electric controller connected mains power. The vibrating Mesh produces aerosol with an average particle size of 5 μm and will remain on continuously until the end of nebulization.
If a heat moisture exchanger (HME) is used during mechanical ventilation, it must be removed from between the nebulizer and airway before nebulization so that it does not filter out and reduce aerosol delivered.
3.5.3 Evaluation by Electrical Impedance Tomography. TIE is a tool of obtaining transverse plane image of any section of the human body by means of low-power electric current. The image is obtained from the electric current or potential detected on the surface of the evaluated area, where each "pixel" image is its impedance or resistivity. Thus, when used in thoracic follow-up, the EIT is able to evaluate the aeration and ventilation of the patient through the following variables: distribution of regional lung ventilation by Tidal Impedance Variation (ΔZ), Ventilation Surface Area (VSA), Percentage of Recruitable Lung (PRLV), Change in End-Expiratory Lung Volume (dEELV) and Respiratory Compliance (Crs) .
Initially, to evaluate the acute pulmonary impact of nebulizer bronchodilator on different ventilatory modes, EIT will be be performed before and immediately after the aerosol administration and repeated with each ventilation mode. Furthermore, the duration of nebulization effect will be evaluated by performing EIT after 1, 2 and 3h in each ventilation mode. There will be a > 4 hour washout between bronchodilator administrations.
An impedance tomography (ENLIGHTER, Timpel, Brazil) will be used with the patient in supine position with a bed elevation of 45◦, so a belt with 32 electrodes will be applied to the chest, in the position corresponding to the 4th - 5th intercostal space on a shaved skin. Electrodes have to be positioned for reading electrocardiograms and a flow sensor that should be attached to the endotracheal tube. After this procedures recording data starts for 3 minutes.
For image acquisition, harmless electrical currents (5-8 nA, 125 KHz) will be injectates through electrode pairs in rotating sequence, and the potential differences Will be captured in other non injetantes electrode. Variations in thoracic impedance will be evaluated through a LabView software (National Instruments, USA) and the data is recorded in separate files for patients for further analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pressure-controled-ventilation (PCV) | Experimental | Drug: salbutamol sulfate and ipratropium bromide, Device: Mesh nebulizationNebulization during mechanical ventilation on a pressure controled ventilation mode. |
| PCV and high PEEP | Experimental | Drug: salbutamol sulfate and ipratropium bromide, Device: Mesh nebulizationNebulization during mechanical ventilation on a pressure controled ventilation mode and PEEP = 15 cmH2O. |
| Pressure suport ventilation (PSV) | Experimental | Drug: salbutamol sulfate and ipratropium bromide, Device: Mesh nebulizationNebulization during mechanical ventilation on a pressure suport ventilation mode. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with asthma or chronic obstructive pulmonary disease (COPD) Invasive mechanical ventilation Hemodynamically stable
Key exclusion criteria (7 listed)
- Prescribed metered dose inhaler (MDI) or intravenous bronchodilators Undrained pneumothorax Bronchopleural fistula Chest trauma Tracheoesophageal fistula Tracheal granulomas Tracheal stenosis PEEP dependence
- Contraindicated disconnection of the MV
- Endotracheal tube diameter less than 7.5
- Do not make part of the protocol of daily sedation
- No regular ventilatory drive when with out sedation
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 |
|---|---|---|
| salbutamol sulfate and ipratropium bromideNebulization with salbutamol sulfate and ipratropium bromide during mechanical ventilation. | Drug | PCV and high PEEP, Pressure suport ventilation (PSV), Pressure-controled-ventilation (PCV) |
| Mesh nebulizationNebulization with Mesh device. | Device | PCV and high PEEP, Pressure suport ventilation (PSV), Pressure-controled-ventilation (PCV) |
Primary outcome
Change in tidal Impedance Variation
Time frame: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
compare regional ventilation distribution by electrical impedance tomography
3 secondary outcomes
Change in compliance of respiratory sistem (cmH2O)
Time frame: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Change in peak expiratory flow (lpm)
Time frame: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Change in End-Expiratory Lung Volume
Time frame: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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.
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 salbutamol sulfate and ipratropium bromide and Mesh nebulization in people with COPD and Asthma, run by Universidade Federal do Rio Grande do Norte 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 May 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?
Results are not available in the source record.
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?
Change in tidal Impedance Variation (time frame: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator). 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 21 May 2019.