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

NCT02566902 | Completed Results

• 1 other identifier: CR-15-047
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in PAS Score (Points on a Scale)

  10 minutes

• Change in PASS Score (Points on a Scale)

  10 minutes

• Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects)

  Up to 24 hours

• Emergency Department Length of Stay (Minutes)

  Up to 24 hours

• Percentage of Patients Experiencing Medication Side Effects (%)

  10 minutes

Study Arms (2)

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.

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.

Device: Breath-Enhanced Nebulizer; Drug: Albuterol; Procedure: Pre-Treatment Spirometry Measurement; Procedure: Post-Treatment Spirometry Measurement

Interventions

T-Piece Nebulizer DEVICE

Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)

T-piece Nebulizer

Breath-Enhanced Nebulizer DEVICE

Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)

Breath-Enhanced Nebulizer

Albuterol DRUG

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

Also known as: albuterol sulfate

Breath-Enhanced Nebulizer; T-piece Nebulizer

Pre-Treatment Spirometry Measurement PROCEDURE

Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.

Breath-Enhanced Nebulizer; T-piece Nebulizer

Post-Treatment Spirometry Measurement PROCEDURE

Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.

Breath-Enhanced Nebulizer; T-piece Nebulizer

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seton Healthcare Family: lead
• University of Texas: collaborator

Study Sites (1)

Dell Children's Medical Center, Emergency Department

Austin, Texas, 78723, United States

Location

Related Publications (27)

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  PMID: 24037768 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.

  PMID: 11732952 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.

  PMID: 18396026 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.

  PMID: 17699806 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.

  PMID: 19828086 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.

  PMID: 10807815 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.

  PMID: 8091320 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.

  PMID: 7925889 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.

  PMID: 9426082 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.

  PMID: 11791687 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.

  PMID: 12877243 BACKGROUND

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

  PMID: 18501026 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.

  PMID: 21333060 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.

  PMID: 15335114 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.

  PMID: 8365298 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.

  PMID: 10393599 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.

  PMID: 21275850 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.

  PMID: 17099024 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.

  PMID: 10654955 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.

  PMID: 21332428 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.

  PMID: 9761804 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.

  PMID: 14709423 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.

  PMID: 18364054 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.

  PMID: 7663792 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.

  PMID: 14716161 BACKGROUND

• 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.

  PMID: 34693935 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.

  PMID: 30392872 DERIVED

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Mike Gardiner, MD
• Organization: University of California - San Diego

magardiner@ucsd.edu

8589668036

Study Officials

• Matthew Wilkinson, MD

  Seton Healthcare Family

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)