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

Phase 2

Terminated

• Conditions: Status Asthmaticus
• Interventions: Drug: Helium-oxygen-driven albuterol nebulizer; Drug: Oxygen

• Registration Number: NCT00410150
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Study First Posted: 2006-12-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2010-09-15
• Results First Submitted QC: 2010-09-15
• Status Verified: 2010-10
• Results First Posted: 2010-10-13
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Heliox-powered albuterol)	Helium-oxygen-driven albuterol nebulizer	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)	Oxygen	Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Primary Outcome Measures

Name	Time	Method
Length of Stay	Hospital discharge	Time to discharge eligibility (hours)

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States