Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Albuterol for Status Asthmaticus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE October 26, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02966184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Albuterol for Status Asthmaticus
Official Title  ICMJE Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Status Asthmaticus
Intervention  ICMJE Drug: preservative free albuterol
Preservative free albuterol for nebulization
Other Names:
  • Albuterol Sulfate Inhalation Solution 0.5%
  • 0487-9901-02
  • 0487-9901-30
Study Arms  ICMJE
  • 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.
    Intervention: Drug: preservative free albuterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 14, 2016)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02966184
Other Study ID Numbers  ICMJE 16.0721
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be made sharable.
Responsible Party Norton Healthcare
Study Sponsor  ICMJE Norton Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tristan Murray, PharmD Norton Healthcare
PRS Account Norton Healthcare
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP