Comparison of Albuterol for Status Asthmaticus

Phase 4

Terminated

• Conditions: Status Asthmaticus
• Interventions: Drug: preservative free albuterol

• Registration Number: NCT02966184
• Lead Sponsor: Norton Healthcare

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Study Start: 2018-09-10
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Results First Submitted: 2020-09-11
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Results First Posted: 2021-05-20
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preservative Free Albuterol	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.

Primary Outcome Measures

Name	Time	Method
Albuterol Administration	Hours until discontinuation of therapy, an average of 72 hours	Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus

Trial Locations

Locations (1)

Norton Children's Hospital; 🇺🇸 Louisville, Kentucky, United States