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Study Drug Backorder
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This study is designed to compare the length of continuous albuterol administration between two different albuterol formulations, BAC containing albuterol versus preservative free albuterol.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzalkonium chloride (BAC) Albuterol | No Intervention | This arm includes the current standard of care which patients receive at the institution. No interventions will be made within this group of patients. | |
| Preservative Free Albuterol | Experimental | This arm includes the preservative free albuterol which is being investigated. Treatment for this arm will follow current standards of care, with the only difference being the albuterol formulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preservative free albuterol | Drug | Preservative free albuterol for nebulization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albuterol Administration | Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus | Hours until discontinuation of therapy, an average of 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tristan Murray, PharmD | Norton Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
IPD will not be made sharable.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were no patients enrolled in the Benzalkonium Chloride-Containing Albuterol group
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Preservative-Free Albuterol |
| 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 | Albuterol Administration | Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus | Study was terminated due to medication backorder and therefore outcome data collection was never performed nor analyzed | Posted | Hours until discontinuation of therapy, an average of 72 hours |
|
Adverse event data was collected only during the patient's admission. Follow-up assessment after discharge did not occur
Our definition of adverse event and or serious adverse event did not differ from clinicaltrials.gov
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tristan Murray, PharmD | Norton Healthcare | 5026295571 | tristan.murray@nortonhealthcare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2018 | Sep 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013224 | Status Asthmaticus |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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.
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |