AsthmaNCT01823926
Asthma and Quantifying Delivery Of Radio Labeled Aerosol
A study testing Noninvasive ventilation, Jet nebulizer and The vibrating mesh nebulizer (VMN) in people with Asthma, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Introduction: Inhalation therapy has been established as an efficient route to treat asthma exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Noninvasive ventilation, Jet nebulizer and The vibrating mesh nebulizer (VMN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Aug 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- stable moderate to severe asthma (FEV1 > 60% and > 80% and PEF with a variation of 30% from the predicted values to moderate and FVE1 > 60% and );
- More than one year elapsed since the diagnosis of asthma;
- None exacerbation in the last six months;
- Age between 18 - 60 years, from both sexes,
- Able to understand verbal commands
- Consent to participate in this protocol.
Who cannot join
- presence of dyspnea;
- smoking history;
- cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax);
- hyperthermia;
- hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg);
- arrhythmia absence;
- pregnancy
- contraindications for use of noninvasive ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantifying Delivery Of Radio Labeled Aerosol During Noninvasive Ventilation To Stable Moderate And Severe Asthmatics: A Randomized, Cross-Over Clinical Trial
Introduction: Inhalation therapy has been established as an efficient route to treat asthma exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.
Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation (NIV).
Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a crossover study. Patients was randomly assigned to participate in both phases of the study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to inhaler using JN positioned in the circuit using a "T" piece, particle size generation in a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask, particle size generation in a one range and connected to electrical energy. NIV was used a bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity counts were performed using a gama camera and regions of interest were delimited. To calculate aerosol mass balance the investigators considered the amount of radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask divided for each of these compartments and represented as a percentage.
- Conditions
- Asthma
- Being tested
- Noninvasive ventilation, Jet nebulizer, The vibrating mesh nebulizer (VMN)
- Keywords
- vibrating mesh nebulizers, noninvasive ventilation, residual volume, pulmonary scintigraphy, radioaerosol, nebulization.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilationOther
Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006).
Jet nebulizerDevice
Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min.
The vibrating mesh nebulizer (VMN)Device
Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Noninvasive ventilation + jet nebulizer Receives: Other: Noninvasive ventilation; Device: Jet nebulizer |
| Experimental Group | Experimental | Noninvasive ventilation + vibrating mesh nebulizer Receives: Other: Noninvasive ventilation; Device: The vibrating mesh nebulizer (VMN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactives counts from the posterior thorax during a period of 500 seconds on a matrix of 256 X 256 matrix. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements.
Measured: 10 mouths
Secondary outcomes (1)
To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.
The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the count in each compartment to the total radioaerosol mass generated by nebulizers. The inhaled radioaerosol was considered the sum of deposition into the upper airways, lungs and stomach.
Measured: 10 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
- Investigators
- Valdecir G Filho, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823926
- Sponsor's protocol ID
- valdecirtese2
- Status last verified
- Dec 2012
- First submitted
- 27 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brandao DC, Lima VM, Filho VG, Silva TS, Campos TF, Dean E, de Andrade AD. Reversal of bronchial obstruction with bi-level positive airway pressure and nebulization in patients with acute asthma. J Asthma. 2009 May;46(4):356-61. doi: 10.1080/02770900902718829.
PubMed 19484669Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.
PubMed 22781558Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.
PubMed 12684289
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Delivery Of Radio Labeled Aerosol During Noninvasive Ventilation To Stable Moderate And Severe Asthmatics: A Randomized, Cross-Over Clinical Trial
- ClinicalTrials.gov ID
- NCT01823926
- Acronym / sponsor ID
- valdecirtese2
- Conditions
- Asthma
- Keywords
- vibrating mesh nebulizers, noninvasive ventilation, residual volume, pulmonary scintigraphy, radioaerosol, nebulization.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Apr 2013 (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.
Introduction: Inhalation therapy has been established as an efficient route to treat asthma exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.
Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation (NIV).
Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a crossover study. Patients was randomly assigned to participate in both phases of the study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to inhaler using JN positioned in the circuit using a "T" piece, particle size generation in a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask, particle size generation in a one range and connected to electrical energy. NIV was used a bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity counts were performed using a gama camera and regions of interest were delimited. To calculate aerosol mass balance the investigators considered the amount of radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask divided for each of these compartments and represented as a percentage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Noninvasive ventilation, Device: Jet nebulizerNoninvasive ventilation + jet nebulizer |
| Experimental Group | Experimental | Other: Noninvasive ventilation, Device: The vibrating mesh nebulizer (VMN)Noninvasive ventilation + vibrating mesh nebulizer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- stable moderate to severe asthma (FEV1 > 60% and > 80% and PEF with a variation of 30% from the predicted values to moderate and FVE1 > 60% and );
- More than one year elapsed since the diagnosis of asthma;
- None exacerbation in the last six months;
- Age between 18 - 60 years, from both sexes,
- Able to understand verbal commands
Key exclusion criteria (8 listed)
- presence of dyspnea;
- smoking history;
- cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax);
- hyperthermia;
- hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg);
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 |
|---|---|---|
| Noninvasive ventilationBilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006). | Other | Control Group, Experimental Group |
| Jet nebulizerBoth nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min. | Device | Control Group |
| The vibrating mesh nebulizer (VMN)Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy. | Device | Experimental Group |
Primary outcome
To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients
Time frame: 10 mouths
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactives counts from the posterior thorax during a period of 500 seconds on a matrix of 256 X 256 matrix. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements.
1 secondary outcome
To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.
Time frame: 10 mouths
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 4 Apr 2013.
- Results publication: PubMed 19484669Brandao DC, Lima VM, Filho VG, Silva TS, Campos TF, Dean E, de Andrade AD. Reversal of bronchial obstruction with bi-level positive airway pressure and nebulization in patients with acute asthma. J Asthma. 2009 May;46(4):356-61. doi: 10.1080/02770900902718829.
- Results publication: PubMed 22781558Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.
- Results publication: PubMed 12684289Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.
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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.
Valdecir G Filho principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation, Jet nebulizer and The vibrating mesh nebulizer (VMN) in people with Asthma, run by Universidade Federal de Pernambuco 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 8 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 4 Apr 2013. 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?
To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients (time frame: 10 mouths). 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 NCT01823926, which also lists 3 linked publications.
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 4 Apr 2013.