AsthmaNCT02566902
Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
A study testing T-Piece Nebulizer, Breath-Enhanced Nebulizer and Albuterol in people with Asthma, run by Seton Healthcare Family at 1 site in United States.
Trial summary
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- T-Piece Nebulizer, Breath-Enhanced Nebulizer and Albuterol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 6 years and < 18 years
- History of physician diagnosed asthma
- Presenting to ED with breathing difficulty or cough
- Initial FEV1 25%-70% predicted
- Parent or guardian speaks English or Spanish.
Who cannot join
- Pediatric Asthma Score of 0
- Pregnancy or breast-feeding
- Immediate resuscitation required
- Chronic lung disease (other than asthma)
- Congenital heart disease
- Neuromuscular disease
- Suspected intrathoracic foreign body
- Allergy or other contraindication to study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Children's Medical Center, Emergency Department
Austin, Texas, 78723
About this study
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
Read the detailed description
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.
- Conditions
- Asthma
- Being tested
- T-Piece Nebulizer, Breath-Enhanced Nebulizer, Albuterol, Pre-Treatment Spirometry Measurement, Post-Treatment Spirometry Measurement
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Piece NebulizerDevice
Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
Breath-Enhanced NebulizerDevice
Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)
AlbuterolDrug
Also called albuterol sulfate
One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
Pre-Treatment Spirometry MeasurementProcedure or surgery
Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.
Post-Treatment Spirometry MeasurementProcedure or surgery
Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.
| Study group | Role | What they receive |
|---|---|---|
| T-piece Nebulizer | Active comparator | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Receives: Device: T-Piece Nebulizer; Drug: Albuterol; Procedure: Pre-Treatment Spirometry Measurement; Procedure: Post-Treatment Spirometry Measurement |
| Breath-Enhanced Nebulizer | Experimental | Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. Receives: Device: Breath-Enhanced Nebulizer; Drug: Albuterol; Procedure: Pre-Treatment Spirometry Measurement; Procedure: Post-Treatment Spirometry Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 (% Predicted)
Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1
Measured: 10 minutes
Secondary outcomes (8)
Change in PAS Score (Points on a Scale)
Based on examination and auscultation of lungs prior to and immediately following albuterol administration.
PAS score is on a scale of 0-10 which is a sum of five separate sub-scores each on a scale of 0-2. The five sub-scores are:
- Respiratory rate (6-12yr/>12yr): <=26/23 (0), 27-30/24-27 (1), >31/28 (2)
- Oxygenation: >95% (0), 90-95 (1), <90 (2)
- Auscultation: clear/end expiratory wheeze (0), expiratory wheeze (1), biphasic wheeze/diminished (2)
- Work of Breathing (accessory muscles): <= 1 (0), 2 (1), >=3 (2)
- Dyspnea: Full sentences (0), Partial sentences (1), Single words (2)
Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PAS calculated as post-treatment PAS minus pre-treatment PAS.
Measured: 10 minutes
Change in PASS Score (Points on a Scale)
Determined by examination and auscultation of lungs to prior to and immediately following albuterol administration.
PASS is a total score on a scale of 0-6 which is calculated as a sum of three sub-scores, each on a scale of 0-2. The sub-scores are:
- Wheezing: None or Mild (0), Moderate (1), Severe wheezing or absent wheezing due to poor air exchange (2)
- Work of breathing (accessory muscle use or retractions): None or mild (0), Moderate (1), Severe (2)
- Prolonged expiration: Normal or mildly prolonged (0), moderately prolonged (1), severely prolonged (2)
Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in PASS calculated as post-treatment PASS minus pre-treatment PASS.
Measured: 10 minutes
Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects)
Admission rate to inpatient hospital will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay.
Measured: Up to 24 hours
Emergency Department Length of Stay (Minutes)
Total length of stay will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay.
Measured: Up to 24 hours
Percentage of Patients Experiencing Medication Side Effects (%)
Subjects and parents/guardians will be asked whether subjects experienced nausea, vomiting, palpitations, headache, dizziness either during (assessed by non-blinded personnel) or following treatment (assessed by blinded personnel during post-treatment assessment). Subject and parent/guardian will also be asked if any "other" side effects were experienced.
Measured: 10 minutes
Total Quantity of Albuterol Given in the Emergency Department (mg)
Cumulative dose of albuterol in mg will be assessed at the time of Emergency Department disposition which will be approximately 3 hours, but will be assessed up to 24 hours depending on duration of ED stay.
Measured: up to 24 hours
Change Respiratory Rate (Breaths Per Minute)
Respiratory rate will be measured by observation and auscultation over 30 seconds prior to and immediately following albuterol administration
Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in respiratory rate calculated as post-treatment respiratory rate minus pre-treatment respiratory rate.
Measured: 10 minutes
Change in Heart Rate (Beats Per Minute)
Blinded research personnel will assess subject's heart rate by auscultation and/or pulse palpation prior to and immediately following albuterol administration.
Pre-treatment assessment at the time of study enrollment. Post-treatment assessment following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in heart rate calculated as post-treatment heart rate minus pre-treatment heart rate.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Matthew Wilkinson, MD, Principal investigator, Seton Healthcare Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566902
- Sponsor's protocol ID
- CR-15-047
- Status last verified
- Apr 2021
- First submitted
- 24 Sep 2015
- Last updated
- 6 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013 Sep 13;2013(9):CD000052. doi: 10.1002/14651858.CD000052.pub3.
PubMed 24037768Tien I, Dorfman D, Kastner B, Bauchner H. Metered-dose inhaler: the emergency department orphan. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1335-9. doi: 10.1001/archpedi.155.12.1335.
PubMed 11732952Mason N, Roberts N, Yard N, Partridge MR. Nebulisers or spacers for the administration of bronchodilators to those with asthma attending emergency departments? Respir Med. 2008 Jul;102(7):993-8. doi: 10.1016/j.rmed.2008.02.009. Epub 2008 Apr 18.
PubMed 18396026Osmond MH, Gazarian M, Henry RL, Clifford TJ, Tetzlaff J; PERC Spacer Study Group. Barriers to metered-dose inhaler/spacer use in Canadian pediatric emergency departments: a national survey. Acad Emerg Med. 2007 Nov;14(11):1106-13. doi: 10.1197/j.aem.2007.05.009. Epub 2007 Aug 15.
PubMed 17699806Scott SD, Osmond MH, O'Leary KA, Graham ID, Grimshaw J, Klassen T; Pediatric Emergency Research Canada (PERC) MDI/spacer Study Group. Barriers and supports to implementation of MDI/spacer use in nine Canadian pediatric emergency departments: a qualitative study. Implement Sci. 2009 Oct 13;4:65. doi: 10.1186/1748-5908-4-65.
PubMed 19828086Mandelberg A, Tsehori S, Houri S, Gilad E, Morag B, Priel IE. Is nebulized aerosol treatment necessary in the pediatric emergency department? Chest. 2000 May;117(5):1309-13. doi: 10.1378/chest.117.5.1309.
PubMed 10807815Newnham DM, Lipworth BJ. Nebuliser performance, pharmacokinetics, airways and systemic effects of salbutamol given via a novel nebuliser delivery system ("Ventstream"). Thorax. 1994 Aug;49(8):762-70. doi: 10.1136/thx.49.8.762.
PubMed 8091320Newman SP, Pitcairn GR, Hooper G, Knoch M. Efficient drug delivery to the lungs from a continuously operated open-vent nebulizer and low pressure compressor system. Eur Respir J. 1994 Jun;7(6):1177-81.
PubMed 7925889Devadason SG, Everard ML, Linto JM, Le Souef PN. Comparison of drug delivery from conventional versus "Venturi" nebulizers. Eur Respir J. 1997 Nov;10(11):2479-83. doi: 10.1183/09031936.97.10112479.
PubMed 9426082Ho SL, Kwong WT, O'Drowsky L, Coates AL. Evaluation of four breath-enhanced nebulizers for home use. J Aerosol Med. 2001 Winter;14(4):467-75. doi: 10.1089/08942680152744677.
PubMed 11791687Rubin BK, Fink JB. The delivery of inhaled medication to the young child. Pediatr Clin North Am. 2003 Jun;50(3):717-31. doi: 10.1016/s0031-3955(03)00049-x.
PubMed 12877243Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
PubMed 18501026Sabato K, Ward P, Hawk W, Gildengorin V, Asselin JM. Randomized controlled trial of a breath-actuated nebulizer in pediatric asthma patients in the emergency department. Respir Care. 2011 Jun;56(6):761-70. doi: 10.4187/respcare.00142. Epub 2011 Feb 11.
PubMed 21333060Lin YZ, Huang FY. Comparison of breath-actuated and conventional constant-flow jet nebulizers in treating acute asthmatic children. Acta Paediatr Taiwan. 2004 Mar-Apr;45(2):73-6.
PubMed 15335114Colacone A, Afilalo M, Wolkove N, Kreisman H. A comparison of albuterol administered by metered dose inhaler (and holding chamber) or wet nebulizer in acute asthma. Chest. 1993 Sep;104(3):835-41. doi: 10.1378/chest.104.3.835.
PubMed 8365298
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
- ClinicalTrials.gov ID
- NCT02566902
- Acronym / sponsor ID
- CR-15-047
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Collaborators
- University of Texas
- Study start
- Oct 2015
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 6 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
Detailed description
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-piece Nebulizer | Active comparator | Device: T-Piece Nebulizer, Drug: Albuterol, Procedure: Pre-Treatment Spirometry Measurement, Procedure: Post-Treatment Spirometry MeasurementPre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. |
| Breath-Enhanced Nebulizer | Experimental | Device: Breath-Enhanced Nebulizer, Drug: Albuterol, Procedure: Pre-Treatment Spirometry Measurement, Procedure: Post-Treatment Spirometry MeasurementPre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≥ 6 years and < 18 years
- History of physician diagnosed asthma
- Presenting to ED with breathing difficulty or cough
- Initial FEV1 25%-70% predicted
- Parent or guardian speaks English or Spanish.
Key exclusion criteria (8 listed)
- Pediatric Asthma Score of 0
- Pregnancy or breast-feeding
- Immediate resuscitation required
- Chronic lung disease (other than asthma)
- Congenital heart disease
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 |
|---|---|---|
| T-Piece NebulizerAlbuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) | Device | T-piece Nebulizer |
| Breath-Enhanced NebulizerAlbuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) | Device | Breath-Enhanced Nebulizer |
| AlbuterolAlso: albuterol sulfateOne time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. | Drug | Breath-Enhanced Nebulizer, T-piece Nebulizer |
| Pre-Treatment Spirometry MeasurementBedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. | Procedure or surgery | Breath-Enhanced Nebulizer, T-piece Nebulizer |
| Post-Treatment Spirometry MeasurementBedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | Procedure or surgery | Breath-Enhanced Nebulizer, T-piece Nebulizer |
Primary outcome
Change in FEV1 (% Predicted)
Time frame: 10 minutes
Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1
8 secondary outcomes
Change in PAS Score (Points on a Scale)
Time frame: 10 minutes
Change in PASS Score (Points on a Scale)
Time frame: 10 minutes
Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects)
Time frame: Up to 24 hours
Emergency Department Length of Stay (Minutes)
Time frame: Up to 24 hours
Percentage of Patients Experiencing Medication Side Effects (%)
Time frame: 10 minutes
Total Quantity of Albuterol Given in the Emergency Department (mg)
Time frame: up to 24 hours
Change Respiratory Rate (Breaths Per Minute)
Time frame: 10 minutes
Change in Heart Rate (Beats Per Minute)
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24037768Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulisers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013 Sep 13;2013(9):CD000052. doi: 10.1002/14651858.CD000052.pub3.
- Background: PubMed 11732952Tien I, Dorfman D, Kastner B, Bauchner H. Metered-dose inhaler: the emergency department orphan. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1335-9. doi: 10.1001/archpedi.155.12.1335.
- Background: PubMed 18396026Mason N, Roberts N, Yard N, Partridge MR. Nebulisers or spacers for the administration of bronchodilators to those with asthma attending emergency departments? Respir Med. 2008 Jul;102(7):993-8. doi: 10.1016/j.rmed.2008.02.009. Epub 2008 Apr 18.
- Background: PubMed 17699806Osmond MH, Gazarian M, Henry RL, Clifford TJ, Tetzlaff J; PERC Spacer Study Group. Barriers to metered-dose inhaler/spacer use in Canadian pediatric emergency departments: a national survey. Acad Emerg Med. 2007 Nov;14(11):1106-13. doi: 10.1197/j.aem.2007.05.009. Epub 2007 Aug 15.
- Background: PubMed 19828086Scott SD, Osmond MH, O'Leary KA, Graham ID, Grimshaw J, Klassen T; Pediatric Emergency Research Canada (PERC) MDI/spacer Study Group. Barriers and supports to implementation of MDI/spacer use in nine Canadian pediatric emergency departments: a qualitative study. Implement Sci. 2009 Oct 13;4:65. doi: 10.1186/1748-5908-4-65.
- Background: PubMed 10807815Mandelberg A, Tsehori S, Houri S, Gilad E, Morag B, Priel IE. Is nebulized aerosol treatment necessary in the pediatric emergency department? Chest. 2000 May;117(5):1309-13. doi: 10.1378/chest.117.5.1309.
- Background: PubMed 8091320Newnham DM, Lipworth BJ. Nebuliser performance, pharmacokinetics, airways and systemic effects of salbutamol given via a novel nebuliser delivery system ("Ventstream"). Thorax. 1994 Aug;49(8):762-70. doi: 10.1136/thx.49.8.762.
- Background: PubMed 7925889Newman SP, Pitcairn GR, Hooper G, Knoch M. Efficient drug delivery to the lungs from a continuously operated open-vent nebulizer and low pressure compressor system. Eur Respir J. 1994 Jun;7(6):1177-81.
- Background: PubMed 9426082Devadason SG, Everard ML, Linto JM, Le Souef PN. Comparison of drug delivery from conventional versus "Venturi" nebulizers. Eur Respir J. 1997 Nov;10(11):2479-83. doi: 10.1183/09031936.97.10112479.
- Background: PubMed 11791687Ho SL, Kwong WT, O'Drowsky L, Coates AL. Evaluation of four breath-enhanced nebulizers for home use. J Aerosol Med. 2001 Winter;14(4):467-75. doi: 10.1089/08942680152744677.
- Background: PubMed 12877243Rubin BK, Fink JB. The delivery of inhaled medication to the young child. Pediatr Clin North Am. 2003 Jun;50(3):717-31. doi: 10.1016/s0031-3955(03)00049-x.
- Background: PubMed 18501026Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
- American Lung Association, Epidemiology and Statistics Unit. Trends in Asthma Morbidity and Mortality. 2012Link provided by the sponsor.
- 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.
Matthew Wilkinson, MD principal investigator
Seton Healthcare Family
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-Piece Nebulizer, Breath-Enhanced Nebulizer and Albuterol in people with Asthma, run by Seton Healthcare Family at 1 site in United States.
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 5 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 6 May 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 FEV1 (% Predicted) (time frame: 10 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 NCT02566902, which also lists 27 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 6 May 2021.