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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL080005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized albuterol 10mg/hr continuous | Active Comparator | Active control arm, 10mg/hr continuous. |
|
| 10mg/hr pulsed | Experimental | Experimental 10mg/hr pulsed albuterol regimen. |
|
| 25mg/hr continuous | Experimental | Experimental 25mg/hr continuous albuterol. |
|
| 25mg/hr pulsed | Experimental | Experimental 25mg/hr pulsed albuterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol | Drug | Nebulized albuterol |
|
| Measure | Description | Time Frame |
|---|---|---|
| %FEV1 | % predicted forced expiratory volume in 1-second as a measure of airway obstruction | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald H Arnold, MD, MPH | Vanderbilt University School of Medicine | Principal Investigator |
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We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebulized Albuterol 10mg/hr Continuous | Active control arm, 10mg/hr continuous. |
| FG001 | 10mg/hr Pulsed | Experimental 10mg/hr pulsed albuterol regimen. |
| FG002 | 25mg/hr Continuous | Experimental 25mg/hr continuous albuterol. |
| FG003 | 25mg/hr Pulsed | Experimental 25mg/hr pulsed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebulized Albuterol 10mg/hr Continuous | Active control arm, 10mg/hr continuous. |
| BG001 | 10mg/hr Pulsed | Experimental 10mg/hr pulsed albuterol regimen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | %FEV1 | % predicted forced expiratory volume in 1-second as a measure of airway obstruction | Posted | Mean | Full Range | %-predicted | 2 hours |
|
2 hours
Report is to data safety and monitoring committee and IRB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nebulized Albuterol 10mg/hr Continuous | Active control arm, 10mg/hr continuous. |
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Limitations: small sample size and not powered to detect differences in outcomes (pilot feasibility study).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Donald H Arnold | Vanderbilt University School of Medicine | 6155790516 | don.arnold@vanderbilt.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| BG002 | 25mg/hr Continuous | Experimental 25mg/hr continuous albuterol. |
| BG003 | 25mg/hr Pulsed | Experimental 25mg/hr pulsed |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | 25mg/hr Pulsed | Experimental 25mg/hr pulsed Albuterol: Nebulized albuterol |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 10mg/hr Pulsed | Experimental 10mg/hr pulsed albuterol regimen. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | 25mg/hr Continuous | Experimental 25mg/hr continuous albuterol. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | 25mg/hr Pulsed | Experimental 25mg/hr pulsed | 0 | 4 | 0 | 4 | 0 | 4 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |