Comparison of Albuterol for Status Asthmaticus

NCT02966184 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 16.0721
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Asthmaticus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: preservative free albuterol

Interventions

preservative free albuterol DRUG

Preservative free albuterol for nebulization

Also known as: Albuterol Sulfate Inhalation Solution 0.5%, 0487-9901-02, 0487-9901-30

Preservative Free Albuterol

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norton Healthcare: lead

Study Sites (1)

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Status Asthmaticus

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Tristan Murray, PharmD
• Organization: Norton Healthcare

tristan.murray@nortonhealthcare.org

5026295571

Study Officials

• Tristan Murray, PharmD

  Norton Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 17, 2016
• Study Start: September 10, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)