Comparison of Albuterol for Status Asthmaticus

Norton Healthcare

Status and phase: Terminated; Phase 4

Conditions: Status Asthmaticus

Treatments: Drug: preservative free albuterol

Study type: Interventional

Funder types: Other

Identifiers

NCT02966184

16.0721

Details and patient eligibility

About

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

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Benzalkonium chloride (BAC) Albuterol

No Intervention group

Description:

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

Preservative Free Albuterol

Experimental group

Description:

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.

Treatment:

Drug: preservative free albuterol