Comparison of Albuterol for Status Asthmaticus

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2018-10-25

Brief Summary

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This study is designed to compare the length of continuous albuterol administration between two different albuterol formulations, BAC containing albuterol versus preservative free albuterol.

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Detailed Description

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The primary objective of this study is to compare the length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol. Secondary objectives include comparison of therapy escalation, asthma scores, forced expiratory volume in one second (FEV1) at discharge, length of hospital stay, and cost.

Conditions

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Status Asthmaticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Benzalkonium chloride (BAC) Albuterol

This arm includes the current standard of care which patients receive at the institution. No interventions will be made within this group of patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Preservative Free Albuterol

This arm includes the preservative free albuterol which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.

Group Type EXPERIMENTAL

preservative free albuterol

Intervention Type DRUG

Preservative free albuterol for nebulization

Interventions

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preservative free albuterol

Preservative free albuterol for nebulization

Intervention Type DRUG

Other Intervention Names

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Albuterol Sulfate Inhalation Solution 0.5% 0487-9901-02 0487-9901-30

Eligibility Criteria

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Inclusion Criteria

* Patients will be included in the study if they are admitted to the 5th floor of Norton Children's Hospital for the treatment of an acute asthma exacerbation, initiated on continuous albuterol inhalation therapy, and are between 5 and 17 years of age.

Exclusion Criteria

* Patients will be excluded from the study if they are transferred from the 5th floor to the Pediatric Intensive Care Unit (PICU), admitted for any indication other than acute asthma exacerbation, or removed from the inpatient asthma protocol for any given reason.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No