An interventional study of Albuterol in Acute Asthma, sponsored by Vanderbilt University Medical Center. Completed. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 16 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active control arm, 10mg/hr continuous.
Drug: Albuterol
Experimental 10mg/hr pulsed albuterol regimen.
Drug: Albuterol
Experimental 25mg/hr continuous albuterol.
Drug: Albuterol
Experimental 25mg/hr pulsed albuterol
Drug: Albuterol
Nebulized albuterol
Also known as: proventil
%FEV1
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Time frame: 2 hours
We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.
| Milestone | Nebulized Albuterol 10mg/hr Continuous | 10mg/hr Pulsed | 25mg/hr Continuous | 25mg/hr Pulsed |
|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
| %-predicted | Nebulized Albuterol 10mg/hr Continuous | 10mg/hr Pulsed | 25mg/hr Continuous | 25mg/hr Pulsed |
|---|---|---|---|---|
| Baseline, pretreatment | 20 (17 to 25) | 34 (19 to 41) | 26 (16 to 36) | 31 (14 to 41) |
| 2-hours (post-treatment) | 41 (32 to 48) | 47 (17 to 77) | 67 (61 to 73) | 44 (34 to 55) |
Collected over 2 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebulized Albuterol 10mg/hr Continuous | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 10mg/hr Pulsed | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 25mg/hr Continuous | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| 25mg/hr Pulsed | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Nebulized Albuterol 10mg/hr Continuous | 10mg/hr Pulsed | 25mg/hr Continuous | 25mg/hr Pulsed | Total |
|---|---|---|---|---|---|
| Mean | 7.8 ± 2 | 7.9 ± 2 | 7.6 ± 4 | 7.7 ± 2 | 7.7 ± 2 |
| Sex: Female, Male(Participants) | Nebulized Albuterol 10mg/hr Continuous | 10mg/hr Pulsed | 25mg/hr Continuous | 25mg/hr Pulsed | Total |
|---|---|---|---|---|---|
| Female | 2 | 2 | 2 | 2 | 8 |
| Male | 2 | 2 | 2 | 2 | 8 |
| Region of Enrollment(participants) | Nebulized Albuterol 10mg/hr Continuous | 10mg/hr Pulsed | 25mg/hr Continuous | 25mg/hr Pulsed | Total |
|---|---|---|---|---|---|
| United States | 4 | 4 | 4 | 4 | 16 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center