Status Asthmaticus
Conditions
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.
Interventions
DRUGpreservative free albuterol
Preservative free albuterol for nebulization
Sponsors
Norton Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Total | Preservative-Free Albuterol |
|---|---|---|
| Age, Continuous | 7.78 years STANDARD_DEVIATION 2.46 | 7.78 years STANDARD_DEVIATION 2.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 8 |
| other Total, other adverse events | 0 / 0 | 0 / 8 |
| serious Total, serious adverse events | 0 / 0 | 0 / 8 |
Outcome results
Primary
Albuterol Administration
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
Population: Study was terminated due to medication backorder and therefore outcome data collection was never performed nor analyzed