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

This study has been terminated.
(Study was stopped after interim analysis and slow enrollment.)
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00410150
First received: December 11, 2006
Last updated: October 22, 2010
Last verified: October 2010

December 11, 2006
October 22, 2010
April 2006
December 2007   (final data collection date for primary outcome measure)
Length of Stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
Time to discharge eligibility (hours)
Hospital length of stay
Complete list of historical versions of study NCT00410150 on ClinicalTrials.gov Archive Site
Not Provided
  • Length of time to clinical asthma score <3
  • Intensive care unit length of stay
  • Frequency of required albuterol nebulizer treatments
  • Incidence of acute respiratory failure
  • Incidence of adverse events
Not Provided
Not Provided
 
Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation
A Prospective, Randomized, Controlled, Single Center Trial of the Use of Heliox in Children Admitted to the Hospital With Status Asthmaticus

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Status Asthmaticus
  • Drug: Helium-oxygen-driven albuterol nebulizer
    Subjects will be treated with continuous albuterol nebs with Heliox
  • Drug: Oxygen
    Subjects will be treated with continuous albuterol nebs in oxygen
  • 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.
    Intervention: Drug: Helium-oxygen-driven albuterol nebulizer
  • 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.
    Intervention: Drug: Oxygen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
24 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00410150
05-11-34-74-067
Yes
Derek Wheeler, Cincinnati Children's Hospital Medical Center
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Derek S Wheeler, M.D. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP