Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation

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ClinicalTrials.gov Identifier: NCT00410150

Recruitment Status : Terminated (Study was stopped after interim analysis and slow enrollment.)

First Posted : December 12, 2006

Results First Posted : October 13, 2010

Last Update Posted : November 7, 2010

Sponsor:

Information provided by:

Children's Hospital Medical Center, Cincinnati

Study Description

Brief Summary:

The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.

Condition or disease	Intervention/treatment	Phase
Status Asthmaticus	Drug: Helium-oxygen-driven albuterol nebulizer Drug: Oxygen	Phase 2

Detailed Description:

We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, I/E ratio, and accessory muscle use). Scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. All scoring using the CAS will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. All children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation >90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. After written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique:

Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.

Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Prospective, Randomized, Controlled, Single Center Trial of the Use of Heliox in Children Admitted to the Hospital With Status Asthmaticus
Study Start Date :	April 2006
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol Levalbuterol hydrochloride Albuterol sulfate Heliox Levalbuterol tartrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1 (Heliox-powered albuterol) Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox.	Drug: Helium-oxygen-driven albuterol nebulizer Subjects will be treated with continuous albuterol nebs with Heliox
Active Comparator: Group 2 (Oxygen-powered albuterol) Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.	Drug: Oxygen Subjects will be treated with continuous albuterol nebs in oxygen

Outcome Measures

Primary Outcome Measures :

Length of Stay [ Time Frame: Hospital discharge ]
Time to discharge eligibility (hours)

Eligibility Criteria

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Ages Eligible for Study:	24 Months to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 2 -18 years;
Previous history of asthma;
Hospital admission for acute asthma exacerbation;
Clinical asthma score greater than or equal to 3

Exclusion Criteria:

Less than 2 years old or over 18 years old;
Known allergy or hypersensitivity to ß-agonists;
Require mechanical ventilation (invasive or non-invasive);
Require FiO2 >0.4;
Failure to obtain informed consent;
Enrollment in another investigational drug or asthma protocol;
Incipient respiratory failure including but limited to respiratory acidosis(pCO2>60 torr), altered mental status and/or excessive work of breathing.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410150

Locations

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

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Principal Investigator:	Derek S Wheeler, M.D.	Children's Hospital Medical Center, Cincinnati

More Information

Additional Information:

Cincinnati Children's Hospital Medical Center This link exits the ClinicalTrials.gov site

Publications:

Rivera ML, Kim TY, Stewart GM, Minasyan L, Brown L. Albuterol nebulized in heliox in the initial ED treatment of pediatric asthma: a blinded, randomized controlled trial. Am J Emerg Med. 2006 Jan;24(1):38-42.

Kim IK, Phrampus E, Venkataraman S, Pitetti R, Saville A, Corcoran T, Gracely E, Funt N, Thompson A. Helium/oxygen-driven albuterol nebulization in the treatment of children with moderate to severe asthma exacerbations: a randomized, controlled trial. Pediatrics. 2005 Nov;116(5):1127-33.

Bandi V, Velamuri S, Sirgi C, Wendt J, Wendt R, Guntupalli K. Deposition pattern of heliox-driven bronchodilator aerosol in the airways of stable asthmatics. J Asthma. 2005 Sep;42(7):583-6.

Lee DL, Hsu CW, Lee H, Chang HW, Huang YC. Beneficial effects of albuterol therapy driven by heliox versus by oxygen in severe asthma exacerbation. Acad Emerg Med. 2005 Sep;12(9):820-7.

Ho AM, Lee A, Karmakar MK, Dion PW, Chung DC, Contardi LH. Heliox vs air-oxygen mixtures for the treatment of patients with acute asthma: a systematic overview. Chest. 2003 Mar;123(3):882-90. Review.

Kress JP, Noth I, Gehlbach BK, Barman N, Pohlman AS, Miller A, Morgan S, Hall JB. The utility of albuterol nebulized with heliox during acute asthma exacerbations. Am J Respir Crit Care Med. 2002 May 1;165(9):1317-21.

Haynes JM, Sargent RJ, Sweeney EL. Use of heliox to avoid intubation in a child with acute severe asthma and hypercapnia. Am J Crit Care. 2003 Jan;12(1):28-30.

Rose JS, Panacek EA, Miller P. Prospective randomized trial of heliox-driven continuous nebulizers in the treatment of asthma in the emergency department. J Emerg Med. 2002 Feb;22(2):133-7.

Dorfman TA, Shipley ER, Burton JH, Jones P, Mette SA. Inhaled heliox does not benefit ED patients with moderate to severe asthma. Am J Emerg Med. 2000 Jul;18(4):495-7.

Schaeffer EM, Pohlman A, Morgan S, Hall JB. Oxygenation in status asthmaticus improves during ventilation with helium-oxygen. Crit Care Med. 1999 Dec;27(12):2666-70.

Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300.

Henderson SO, Acharya P, Kilaghbian T, Perez J, Korn CS, Chan LS. Use of heliox-driven nebulizer therapy in the treatment of acute asthma. Ann Emerg Med. 1999 Feb;33(2):141-6.

Kudukis TM, Manthous CA, Schmidt GA, Hall JB, Wylam ME. Inhaled helium-oxygen revisited: effect of inhaled helium-oxygen during the treatment of status asthmaticus in children. J Pediatr. 1997 Feb;130(2):217-24.

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Responsible Party:	Derek Wheeler, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier:	NCT00410150
Other Study ID Numbers:	05-11-34-74-067
First Posted:	December 12, 2006 Key Record Dates
Results First Posted:	October 13, 2010
Last Update Posted:	November 7, 2010
Last Verified:	October 2010

Keywords provided by Children's Hospital Medical Center, Cincinnati:


Status asthmaticus Asthma Helium Children

Additional relevant MeSH terms:

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Status Asthmaticus Asthma Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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