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
  Purpose

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 Intervention Phase
Status Asthmaticus
Drug: Helium-oxygen-driven albuterol nebulizer
Drug: Oxygen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Length of Stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
    Time to discharge eligibility (hours)


Enrollment: 42
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   24 Months to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410150

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Derek S Wheeler, M.D. Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:

Responsible Party: Derek Wheeler, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00410150     History of Changes
Other Study ID Numbers: 05-11-34-74-067
Study First Received: December 11, 2006
Results First Received: September 15, 2010
Last Updated: October 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Status asthmaticus
Asthma
Helium
Children

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

ClinicalTrials.gov processed this record on July 23, 2014