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Comparison of Albuterol for Status Asthmaticus

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ClinicalTrials.gov Identifier: NCT02966184
Recruitment Status : Suspended (Study Drug Backorder)
First Posted : November 17, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Norton Healthcare

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.

Condition or disease Intervention/treatment Phase
Status Asthmaticus Drug: preservative free albuterol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
No Intervention: Benzalkonium chloride (BAC) Albuterol
This arm includes the current standard of care which patients receive at the institution. No interventions will be made within this group of patients.
Experimental: Preservative Free Albuterol
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.
Drug: preservative free albuterol
Preservative free albuterol for nebulization
Other Names:
  • Albuterol Sulfate Inhalation Solution 0.5%
  • 0487-9901-02
  • 0487-9901-30




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966184


Locations
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United States, Kentucky
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Norton Healthcare
Investigators
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Principal Investigator: Tristan Murray, PharmD Norton Healthcare

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Responsible Party: Norton Healthcare
ClinicalTrials.gov Identifier: NCT02966184     History of Changes
Other Study ID Numbers: 16.0721
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made sharable.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Albuterol
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Benzalkonium Compounds
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents