Comparison of Albuterol for Status Asthmaticus

Status Asthmaticus Clinical Trial

Official title:

Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02966184
• Other study ID #: 16.0721
• Status: Terminated
• Phase: Phase 4
• Start date: September 10, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: May 2021
• Source: Norton Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

Drug:
• preservative free albuterol
Preservative free albuterol for nebulization

Locations

Country	Name	City	State
United States	Norton Children's Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Norton Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Albuterol Administration	Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus	Hours until discontinuation of therapy, an average of 72 hours