Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma

Asthma Clinical Trial

Official title:

Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566902
• Other study ID #: CR-15-047
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2021
• Source: Seton Healthcare Family
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• T-Piece Nebulizer
Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
• Breath-Enhanced Nebulizer
Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)

Drug:
• Albuterol
One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Dell Children's Medical Center, Emergency Department	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Seton Healthcare Family	University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (25)

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. Erratum in: Chest. 2007 Aug;132(2):738. — View Citation

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. — View Citation

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;(9):CD000052. doi: 10.1002/14651858.CD000052.pub3. Review. — View Citation

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. — View Citation

Devadason SG, Everard ML, Linto JM, Le Souëf PN. Comparison of drug delivery from conventional versus "Venturi" nebulizers. Eur Respir J. 1997 Nov;10(11):2479-83. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Aug 15. — View Citation

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. — View Citation

Rubin BK, Fink JB. The delivery of inhaled medication to the young child. Pediatr Clin North Am. 2003 Jun;50(3):717-31. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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	10 minutes
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: 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.	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: 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.	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.	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.	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.	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.	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.	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.	10 minutes

External Links

•   American Lung Association, Epidemiology and Statistics Unit. Trends in Asthma Morbidity and Mortality. 2012