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| Name | Class |
|---|---|
| University of Texas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-Piece Nebulizer | Device | Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Wilkinson, MD | Seton Healthcare Family | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dell Children's Medical Center, Emergency Department | Austin | Texas | 78723 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24037768 | Background | 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. | |
| 11732952 | Background | Tien 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. |
| Label | URL |
|---|---|
| American Lung Association, Epidemiology and Statistics Unit. Trends in Asthma Morbidity and Mortality. 2012 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | T-piece Nebulizer | 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. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| FG001 | Breath-Enhanced Nebulizer | 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. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T-piece Nebulizer | 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. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Eight subjects unable to complete post-treatment spirometry (three in T-piece group, five in breath-enhanced group) | Posted | Mean | 95% Confidence Interval | %predicted | 10 minutes |
|
Duration of emergency department visit until the time of discharge or admission - up to 24 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T-piece Nebulizer | 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. T-Piece Nebulizer: Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shakiness, Jitteriness | Nervous system disorders | Systematic Assessment | Subjective shakiness or dizziness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Gardiner, MD | University of California - San Diego | 8589668036 | magardiner@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2017 | Mar 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Breath-Enhanced Nebulizer | Device | Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) |
|
| Albuterol | Drug | One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. |
|
|
| Pre-Treatment Spirometry Measurement | Procedure | Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. |
|
| Post-Treatment Spirometry Measurement | Procedure | Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
|
| 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:
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. | 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. | 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. | 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. | 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. | 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. | 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. | 10 minutes |
| 18396026 | Background | Mason 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. |
| 17699806 | Background | Osmond 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. |
| 19828086 | Background | Scott 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. |
| 10807815 | Background | Mandelberg 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. |
| 8091320 | Background | Newnham 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. |
| 7925889 | Background | Newman 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. |
| 9426082 | Background | Devadason 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. |
| 11791687 | Background | Ho 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. |
| 12877243 | Background | Rubin 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. |
| 18501026 | Background | Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5. |
| 21333060 | Background | Sabato 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. |
| 15335114 | Background | Lin 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. |
| 8365298 | Background | Colacone 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. |
| 10393599 | Background | Schuh S, Johnson DW, Stephens D, Callahan S, Winders P, Canny GJ. Comparison of albuterol delivered by a metered dose inhaler with spacer versus a nebulizer in children with mild acute asthma. J Pediatr. 1999 Jul;135(1):22-7. doi: 10.1016/s0022-3476(99)70322-7. |
| 21275850 | Background | Wilkinson M, Bulloch B, Garcia-Filion P, Keahey L. Efficacy of racemic albuterol versus levalbuterol used as a continuous nebulization for the treatment of acute asthma exacerbations: a randomized, double-blind, clinical trial. J Asthma. 2011 Mar;48(2):188-93. doi: 10.3109/02770903.2011.554939. Epub 2011 Jan 29. |
| 17099024 | Background | Aggarwal AN, Gupta D, Jindal SK. The relationship between FEV1 and peak expiratory flow in patients with airways obstruction is poor. Chest. 2006 Nov;130(5):1454-61. doi: 10.1378/chest.130.5.1454. |
| 10654955 | Background | Eid N, Yandell B, Howell L, Eddy M, Sheikh S. Can peak expiratory flow predict airflow obstruction in children with asthma? Pediatrics. 2000 Feb;105(2):354-8. doi: 10.1542/peds.105.2.354. |
| 21332428 | Background | Schneider WV, Bulloch B, Wilkinson M, Garcia-Filion P, Keahey L, Hostetler M. Utility of portable spirometry in a pediatric emergency department in children with acute exacerbation of asthma. J Asthma. 2011 Apr;48(3):248-52. doi: 10.3109/02770903.2011.555036. Epub 2011 Feb 21. |
| 9761804 | Background | Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5. doi: 10.1056/NEJM199810083391503. |
| 14709423 | Background | Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015. |
| 18364054 | Background | Barr RG, Stemple KJ, Mesia-Vela S, Basner RC, Derk SJ, Henneberger PK, Milton DK, Taveras B. Reproducibility and validity of a handheld spirometer. Respir Care. 2008 Apr;53(4):433-41. |
| 7663792 | Background | Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. doi: 10.1164/ajrccm.152.3.7663792. No abstract available. |
| 14716161 | Background | Gorelick MH, Stevens MW, Schultz T, Scribano PV. Difficulty in obtaining peak expiratory flow measurements in children with acute asthma. Pediatr Emerg Care. 2004 Jan;20(1):22-6. doi: 10.1097/01.pec.0000106239.72265.16. |
| 34693935 | Derived | Gardiner MA, Wilkinson MH. Interrater Reliability of the Pediatric Asthma Score. Pediatr Emerg Care. 2022 Apr 1;38(4):143-146. doi: 10.1097/PEC.0000000000002556. |
| 30392872 | Derived | Gardiner MA, Wilkinson MH. Randomized Clinical Trial Comparing Breath-Enhanced to Conventional Nebulizers in the Treatment of Children with Acute Asthma. J Pediatr. 2019 Jan;204:245-249.e2. doi: 10.1016/j.jpeds.2018.08.083. Epub 2018 Nov 2. |
| BG001 | Breath-Enhanced Nebulizer | 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. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Asthma Severity | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Duration of symptoms (days) | Median | Inter-Quartile Range | days |
|
| Initial RR (bpm) | Mean | Standard Deviation | breaths/min |
|
| Initial O2 | Mean | Standard Deviation | %saturation |
|
| Initial PAS score | Determined by examination and auscultation of lungs prior to 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:
| Median | Inter-Quartile Range | units on a scale |
|
| Initial PASS score | Determined by examination and auscultation of lungs prior to 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:
| Median | Inter-Quartile Range | units on a scale |
|
| Initial FEV1 (% predicted) | Mean | Standard Deviation | %predicted |
|
| OG001 | Breath-Enhanced Nebulizer | 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. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. |
|
|
|
| Secondary | 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:
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. | Posted | Median | Inter-Quartile Range | score on a scale | 10 minutes |
|
|
|
|
| Secondary | 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:
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. | Posted | Median | Inter-Quartile Range | score on a scale | 10 minutes |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | minutes | Up to 24 hours |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 10 minutes |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mg | up to 24 hours |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | breaths/min | 10 minutes |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | beats per minute | 10 minutes |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 5 |
| 58 |
| EG001 | Breath-Enhanced Nebulizer | 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. Breath-Enhanced Nebulizer: Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA) Albuterol: One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes. Pre-Treatment Spirometry Measurement: Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer. Post-Treatment Spirometry Measurement: Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer. | 0 | 57 | 0 | 57 | 5 | 57 |
|
| Dizziness | Nervous system disorders | Systematic Assessment | Subjective dizziness |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Weakness | Nervous system disorders | Non-systematic Assessment | Subjective feeling of weakness |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |