Acute Asthma
Conditions
Keywords
Asthma, Acute asthma, Pediatrics
Brief summary
Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.
Detailed description
The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.
Interventions
DRUGAlbuterol
Nebulized albuterol
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Doctor diagnosed asthma * Acute asthma exacerbation * Treatment with systemic corticosteroids and nebulized albuterol * Ages 5 to 17 years
Exclusion criteria
* Other acute or chronic lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| %FEV1 | 2 hours | % predicted forced expiratory volume in 1-second as a measure of airway obstruction |
Participant flow
Recruitment details
We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.
Participants by arm
| Arm | Count |
|---|---|
| Nebulized Albuterol 10mg/hr Continuous Active control arm, 10mg/hr continuous. | 4 |
| 10mg/hr Pulsed Experimental 10mg/hr pulsed albuterol regimen. | 4 |
| 25mg/hr Continuous Experimental 25mg/hr continuous albuterol. | 4 |
| 25mg/hr Pulsed Experimental 25mg/hr pulsed | 4 |
| Total | 16 |
Baseline characteristics
| Characteristic | Nebulized Albuterol 10mg/hr Continuous | 10mg/hr Pulsed | 25mg/hr Continuous | 25mg/hr Pulsed | Total |
|---|---|---|---|---|---|
| Age, Continuous | 7.8 years STANDARD_DEVIATION 2 | 7.9 years STANDARD_DEVIATION 2 | 7.6 years STANDARD_DEVIATION 4 | 7.7 years STANDARD_DEVIATION 2 | 7.7 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants | 4 participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
%FEV1
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nebulized Albuterol 10mg/hr Continuous | %FEV1 | Baseline, pretreatment | 20 %-predicted |
| Nebulized Albuterol 10mg/hr Continuous | %FEV1 | 2-hours (post-treatment) | 41 %-predicted |
| 10mg/hr Pulsed | %FEV1 | 2-hours (post-treatment) | 47 %-predicted |
| 10mg/hr Pulsed | %FEV1 | Baseline, pretreatment | 34 %-predicted |
| 25mg/hr Continuous | %FEV1 | Baseline, pretreatment | 26 %-predicted |
| 25mg/hr Continuous | %FEV1 | 2-hours (post-treatment) | 67 %-predicted |
| 25mg/hr Pulsed | %FEV1 | Baseline, pretreatment | 31 %-predicted |
| 25mg/hr Pulsed | %FEV1 | 2-hours (post-treatment) | 44 %-predicted |