NCT00410150

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 13, 2010

Completed
Last Updated

November 8, 2010

Status Verified

October 1, 2010

Enrollment Period

1.7 years

First QC Date

December 11, 2006

Results QC Date

September 15, 2010

Last Update Submit

October 22, 2010

Conditions

Status Asthmaticus

Keywords

Status asthmaticusAsthmaHeliumChildren

Outcome Measures

Primary Outcomes (1)

  • Length of Stay

    Time to discharge eligibility (hours)

    Hospital discharge

Study Arms (2)

Group 1 (Heliox-powered albuterol)

EXPERIMENTAL

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

Group 2 (Oxygen-powered albuterol)

ACTIVE COMPARATOR

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

Interventions

Helium-oxygen-driven albuterol nebulizerDRUG

Subjects will be treated with continuous albuterol nebs with Heliox

Group 1 (Heliox-powered albuterol)
OxygenDRUG

Subjects will be treated with continuous albuterol nebs in oxygen

Group 2 (Oxygen-powered albuterol)

Eligibility Criteria

Age24 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (13)

  • 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. doi: 10.1016/j.ajem.2005.06.007.

    PMID: 16338507BACKGROUND

  • 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. doi: 10.1542/peds.2004-2136.

    PMID: 16263999BACKGROUND

  • 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. doi: 10.1080/02770900500216135.

    PMID: 16169793BACKGROUND

  • 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. doi: 10.1197/j.aem.2005.04.020.

    PMID: 16141015BACKGROUND

  • 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. doi: 10.1378/chest.123.3.882.

    PMID: 12628892BACKGROUND

  • 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. doi: 10.1164/rccm.9907035.

    PMID: 11991886BACKGROUND

  • 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. No abstract available.

    PMID: 12526234BACKGROUND

  • 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. doi: 10.1016/s0736-4679(01)00454-1.

    PMID: 11858916BACKGROUND

  • 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. doi: 10.1053/ajem.2000.7365. No abstract available.

    PMID: 10919545BACKGROUND

  • 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. doi: 10.1097/00003246-199912000-00010.

    PMID: 10628607BACKGROUND

  • Kass JE, Terregino CA. The effect of heliox in acute severe asthma: a randomized controlled trial. Chest. 1999 Aug;116(2):296-300. doi: 10.1378/chest.116.2.296.

    PMID: 10453854BACKGROUND

  • 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. doi: 10.1016/s0196-0644(99)70386-0.

    PMID: 9922408BACKGROUND

  • 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. doi: 10.1016/s0022-3476(97)70346-9.

    PMID: 9042123BACKGROUND

Related Links

MeSH Terms

Conditions

Status AsthmaticusAsthma

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Results Point of Contact

Title
Dr. Derek Wheeler
Organization
Cincinnati Children's Hospital Medical Center
derek.wheeler@cchmc.org
513-636-4239

Study Officials

  • Derek S Wheeler, M.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 8, 2010

Results First Posted

October 13, 2010

Record last verified: 2010-10

Locations

US(1)