Comparison of Albuterol for Status Asthmaticus

• Sponsor: Norton Healthcare (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02966184
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 5.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Status Asthmaticus	Drug: preservative free albuterol	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Oct 25, 2018
• Actual Study Completion Date: Oct 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Drug: preservative free albuterol; Preservative free albuterol for nebulization; Other Names: Albuterol Sulfate Inhalation Solution 0.5% 0487-9901-02 0487-9901-30

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norton Children's Hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• Norton Healthcare

Investigators

• Principal Investigator: Tristan Murray, PharmD, Norton Healthcare

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 18, 2018

More Information

Publications

None provided.

• Responsible Party: Norton Healthcare
• ClinicalTrials.gov Identifier: NCT02966184
• Other Study ID Numbers: 16.0721
• First Posted: Nov 17, 2016
• Last Update Posted: May 20, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Status Asthmaticus; Albuterol

Study Results

Participant Flow

Recruitment Details

According to the study design, we had to assent/consent (but not enrolled) far more patients than would be eligible for study inclusion/enrollment. This was to prevent a delay in therapy if the patient needed to be administered continuous albuterol immediately. Most consented patients did not get assigned to one of the 'study nursing units' so they were not eligible for study enrollment. Only 8 patients met the criteria for enrollment.

Arm/Group Title	Benzalkonium Chloride-Containing Albuterol	Preservative-Free Albuterol
Arm/Group Description	This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.	This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
Period Title: Overall Study
STARTED	0	8
COMPLETED	0	0
NOT COMPLETED	0	8

Baseline Characteristics

Arm/Group Title	Benzalkonium Chloride-Containing Albuterol	Preservative-Free Albuterol	Total
Arm/Group Description	This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.	This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.	Total of all reporting groups
Overall Participants	0	8	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.78 (2.46)	7.78 (2.46)
Sex: Female, Male (Count of Participants)
Female	3 Infinity	3 37.5%
Male	5 Infinity	5 62.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 NaN	0 0%
Asian	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 NaN	0 0%
Black or African American	6 Infinity	6 75%
White	2 Infinity	2 25%
More than one race	0 NaN	0 0%
Unknown or Not Reported	0 NaN	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was terminated due to medication backorder and therefore outcome data collection was never performed nor analyzed

Arm/Group Title	Benzalkonium Chloride-Containing Albuterol	Preservative-Free Albuterol
Arm/Group Description	This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.	This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse event data was collected only during the patient's admission. Follow-up assessment after discharge did not occur
Adverse Event Reporting Description	Our definition of adverse event and or serious adverse event did not differ from clinicaltrials.gov
Arm/Group Title	Benzalkonium Chloride-Containing Albuterol		Preservative-Free Albuterol
Arm/Group Description	This arm includes the current standard of care (preservative-containing albuterol nebulization) which patients receive at the institution. No interventions will be made within this group of patients.		This arm includes the preservative-free albuterol nebulization which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation.
All Cause Mortality
	Benzalkonium Chloride-Containing Albuterol		Preservative-Free Albuterol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/8 (0%)
Serious Adverse Events
	Benzalkonium Chloride-Containing Albuterol		Preservative-Free Albuterol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Benzalkonium Chloride-Containing Albuterol		Preservative-Free Albuterol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.