A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

Asthma Clinical Trial

Official title:

A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777125
• Other study ID #: LeBonheurCH
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: August 14, 2017
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2017
• Source: Le Bonheur Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.

Description:

Albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. There is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. The effectiveness of breath actuated nebulization compared to MDI for treating asthma exacerbations is less well defined.

Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.

Exclusion Criteria:

• Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease

• Congenital heart disease, tracheostomy, or were receiving diuretic therapy.

• Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Metered Dose Inhaler
A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths.
• Breath Actuated Nebulizer
The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital	University of Tennessee Health Science Center

References & Publications (32)

Altamimi S, Robertson G, Jastaniah W, Davey A, Dehghani N, Chen R, Leung K, Colbourne M. Single-dose oral dexamethasone in the emergency management of children with exacerbations of mild to moderate asthma. Pediatr Emerg Care. 2006 Dec;22(12):786-93. — View Citation

Amirav I, Newhouse MT. Metered-dose inhaler accessory devices in acute asthma: efficacy and comparison with nebulizers: a literature review. Arch Pediatr Adolesc Med. 1997 Sep;151(9):876-82. Review. — View Citation

Arunthari V, Bruinsma RS, Lee AS, Johnson MM. A prospective, comparative trial of standard and breath-actuated nebulizer: efficacy, safety, and satisfaction. Respir Care. 2012 Aug;57(8):1242-7. doi: 10.4187/respcare.01450. Epub 2012 Feb 17. — View Citation

Castro-Rodriguez JA, Rodrigo GJ. beta-agonists through metered-dose inhaler with valved holding chamber versus nebulizer for acute exacerbation of wheezing or asthma in children under 5 years of age: a systematic review with meta-analysis. J Pediatr. 2004 Aug;145(2):172-7. Review. — View Citation

Chameides L, Ralston M, American Academy of Pediatrics, American Heart Association. Pediatric Advances Life Support. Dallas, Tx: American Heart Association;2011

Doan Q, Shefrin A, Johnson D. Cost-effectiveness of metered-dose inhalers for asthma exacerbations in the pediatric emergency department. Pediatrics. 2011 May;127(5):e1105-11. doi: 10.1542/peds.2010-2963. Epub 2011 Apr 4. — View Citation

Goggin N, Macarthur C, Parkin PC. Randomized trial of the addition of ipratropium bromide to albuterol and corticosteroid therapy in children hospitalized because of an acute asthma exacerbation. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1329-34. — View Citation

Griffiths B, Ducharme FM. Combined inhaled anticholinergics and short-acting beta2-agonists for initial treatment of acute asthma in children. Cochrane Database Syst Rev. 2013 Aug 21;(8):CD000060. doi: 10.1002/14651858.CD000060.pub2. Review. — View Citation

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. — View Citation

Hussain-Rizvi A, Kunkov S, Crain EF. Does parental involvement in pediatric emergency department asthma treatment affect home management? J Asthma. 2009 Oct;46(8):792-5. — View Citation

Kerem E, Levison H, Schuh S, O'Brodovich H, Reisman J, Bentur L, Canny GJ. Efficacy of albuterol administered by nebulizer versus spacer device in children with acute asthma. J Pediatr. 1993 Aug;123(2):313-7. — View Citation

Leung K, Louca E, Coates AL. Comparison of breath-enhanced to breath-actuated nebulizers for rate, consistency, and efficiency. Chest. 2004 Nov;126(5):1619-27. — View Citation

Leversha AM, Campanella SG, Aickin RP, Asher MI. Costs and effectiveness of spacer versus nebulizer in young children with moderate and severe acute asthma. J Pediatr. 2000 Apr;136(4):497-502. — View Citation

Liu LL, Gallaher MM, Davis RL, Rutter CM, Lewis TC, Marcuse EK. Use of a respiratory clinical score among different providers. Pediatr Pulmonol. 2004 Mar;37(3):243-8. — View Citation

Naar-King S, Lam P, Ellis D, Bruzzese JM, Secord E. Asthma medication device skills in high-risk African American adolescents. J Asthma. 2013 Aug;50(6):579-82. doi: 10.3109/02770903.2013.786725. Epub 2013 May 28. — View Citation

National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. Erratum in: J Allergy Clin Immunol. 2008 Jun;121(6):1330. — 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

Parone D, Stauss M, Reed CR, Sherman B, Smith L, Johnson R, Milcarek B, Hunter K. A comparative study of two nebulizers in the emergency department: breath-actuated nebulizer and handheld nebulizer. J Emerg Nurs. 2014 Mar;40(2):131-7. doi: 10.1016/j.jen.2012.10.006. Epub 2013 Jan 29. — View Citation

Ploin D, Chapuis FR, Stamm D, Robert J, David L, Chatelain PG, Dutau G, Floret D. High-dose albuterol by metered-dose inhaler plus a spacer device versus nebulization in preschool children with recurrent wheezing: A double-blind, randomized equivalence trial. Pediatrics. 2000 Aug;106(2 Pt 1):311-7. Erratum in: Pediatrics 2000 Oct;106(4):623. — View Citation

Ram FS, Wright J, Brocklebank D, White JE. Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering beta (2 )agonists bronchodilators in asthma. BMJ. 2001 Oct 20;323(7318):901-5. — View Citation

Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12. — View Citation

Reznik M, Silver EJ, Cao Y. Evaluation of MDI-spacer utilization and technique in caregivers of urban minority children with persistent asthma. J Asthma. 2014 Mar;51(2):149-54. doi: 10.3109/02770903.2013.854379. Epub 2013 Oct 22. — View Citation

Rodrigo C, Rodrigo G. Salbutamol treatment of acute severe asthma in the ED: MDI versus hand-held nebulizer. Am J Emerg Med. 1998 Nov;16(7):637-42. — View Citation

Rubilar L, Castro-Rodriguez JA, Girardi G. Randomized trial of salbutamol via metered-dose inhaler with spacer versus nebulizer for acute wheezing in children less than 2 years of age. Pediatr Pulmonol. 2000 Apr;29(4):264-9. — 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

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

Staggs L, Peek M, Southard G, Gracely E, Baxendale S, Cross KP, Kim IK. Evaluating the length of stay and value of time in a pediatric emergency department with two models by comparing two different albuterol delivery systems. J Med Econ. 2012;15(4):704-11. doi: 10.3111/13696998.2012.674587. Epub 2012 Mar 23. — View Citation

Titus MO, Eady M, King L, Bowman CM. Effectiveness of a breath-actuated nebulizer device on asthma care in the pediatric emergency department. Clin Pediatr (Phila). 2012 Dec;51(12):1150-4. doi: 10.1177/0009922812458356. Epub 2012 Aug 28. — View Citation

Wyatt EL, Borland ML, Doyle SK, Geelhoed GC. Metered-dose inhaler ipratropium bromide in moderate acute asthma in children: A single-blinded randomised controlled trial. J Paediatr Child Health. 2015 Feb;51(2):192-8. doi: 10.1111/jpc.12692. Epub 2014 Jul 14. — View Citation

Zar HJ, Asmus MJ, Weinberg EG. A 500-ml plastic bottle: an effective spacer for children with asthma. Pediatr Allergy Immunol. 2002 Jun;13(3):217-22. — View Citation

Zar HJ, Brown G, Donson H, Brathwaite N, Mann MD, Weinberg EG. Home-made spacers for bronchodilator therapy in children with acute asthma: a randomised trial. Lancet. 1999 Sep 18;354(9183):979-82. — View Citation

Zorc JJ, Pusic MV, Ogborn CJ, Lebet R, Duggan AK. Ipratropium bromide added to asthma treatment in the pediatric emergency department. Pediatrics. 1999 Apr;103(4 Pt 1):748-52. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant's Admitted to the Hospital for Further Treatment	Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.	6 hours
Secondary	Emergency Department Length of Stay	Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.	6 hours
Secondary	Number of Patients With Tachycardia After Treatment	Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.	6 hours
Secondary	Number of Patients Requiring Ondansetron Dosing	Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.	6 hours
Secondary	Number of Participants Requiring Repeat Visits	Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.	Within 7 days of initial presentation