Back to resultsComparison of Albuterol for Status Asthmaticus
Primary Purpose
Status Asthmaticus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
preservative free albuterol
Sponsored by
About this trial
This is an interventional treatment trial for Status Asthmaticus
Eligibility Criteria
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.
Sites / Locations
- Norton Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Benzalkonium chloride (BAC) Albuterol
Preservative Free Albuterol
Arm 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.
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.
Outcomes
Primary Outcome Measures
Albuterol Administration
Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02966184
Brief Title
Comparison of Albuterol for Status Asthmaticus
Official Title
Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Study Drug Backorder
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norton Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Asthmaticus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Benzalkonium chloride (BAC) Albuterol
Arm Type
No Intervention
Arm 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.
Arm Title
Preservative Free Albuterol
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
preservative free albuterol
Other Intervention Name(s)
Albuterol Sulfate Inhalation Solution 0.5%, 0487-9901-02, 0487-9901-30
Intervention Description
Preservative free albuterol for nebulization
Primary Outcome Measure Information:
Title
Albuterol Administration
Description
Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus
Time Frame
Hours until discontinuation of therapy, an average of 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristan Murray, PharmD
Organizational Affiliation
Norton Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made sharable.
Learn more about this trial
Comparison of Albuterol for Status Asthmaticus
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