Trial Outcomes & Findings for Comparison of Albuterol for Status Asthmaticus (NCT 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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

Hours until discontinuation of therapy, an average of 72 hours

Results posted on

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

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

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=7 Participants	7.78 years STANDARD_DEVIATION 2.46 • n=5 Participants
Sex: Female, Male Female	—	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	—	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	6 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Hours until discontinuation of therapy, an average of 72 hours

Population: 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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Preservative-Free Albuterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tristan Murray, PharmD

Norton Healthcare

Phone: 5026295571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place