Trial Outcomes & Findings for Comparison of Albuterol for Status Asthmaticus (NCT NCT02966184)
NCT ID: NCT02966184
Last Updated: 2021-05-20
Results Overview
Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus
TERMINATED
PHASE4
8 participants
Hours until discontinuation of therapy, an average of 72 hours
2021-05-20
Participant Flow
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.
Participant milestones
| Measure |
Benzalkonium Chloride-Containing Albuterol
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.
|
Preservative-Free Albuterol
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.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Albuterol for Status Asthmaticus
Baseline characteristics by cohort
| Measure |
Benzalkonium Chloride-Containing Albuterol
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.
|
Preservative-Free Albuterol
n=8 Participants
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
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
7.78 years
STANDARD_DEVIATION 2.46 • n=107 Participants
|
7.78 years
STANDARD_DEVIATION 2.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
—
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
—
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Hours until discontinuation of therapy, an average of 72 hoursPopulation: Study was terminated due to medication backorder and therefore outcome data collection was never performed nor analyzed
Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus
Outcome measures
Outcome data not reported
Adverse Events
Benzalkonium Chloride-Containing Albuterol
Preservative-Free Albuterol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place