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Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Primary Purpose

Oxygen Consumption

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Albuterol
Levalbuterol
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oxygen Consumption focused on measuring Beta Agonists, Asthma, Albuterol, Levalbuterol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria:

  • Coronary artery disease, history of intolerance to beta agonists

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Albuterol 5 mg first, then levalbuterol 2.5 mg

    Levalbuterol 2.5 mg first, then albuterol 5 mg

    Arm Description

    Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

    Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

    Outcomes

    Primary Outcome Measures

    Oxygen Consumption
    Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol

    Secondary Outcome Measures

    Heart Rate
    Vital signs including heart rate will be measured for up to 60 minutes following beta agonist

    Full Information

    First Posted
    June 10, 2016
    Last Updated
    October 7, 2020
    Sponsor
    Children's Hospital Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02802111
    Brief Title
    Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults
    Official Title
    Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Hospital Los Angeles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction. Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR) following administration of albuterol and
    Detailed Description
    Inhaled β2 adrenoceptor agonists are frequently used to treat reversible lower airway obstruction, or to assist with mucociliary clearance. Albuterol remains the most commonly used β agonist and contains a racemic mixture of two enantiomers. The R enantiomer is the active moiety responsible for the bronchodilation, while the S enantiomer was initially thought to be inactive, although recent studies suggest otherwise. Levalbuterol contains the single R form enantiomer, and in clinical practice it is frequently prescribed not only because of its bronchodilator benefits, but to limit cardiovascular toxicity. Adverse cardiovascular effects remain the main dose-limiting factor for β2 agonists. The primary objective of the investigators study is to compare the change in oxygen consumption following albuterol to that of levalbuterol, in healthy adult volunteers. The investigators hypothesized there would be no clinically significant difference in V'O2 between the two drugs, if equal doses of the R-enantiomer were administered. Secondary objectives were to compare the changes in heart rate and other vital signs between the two drugs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oxygen Consumption
    Keywords
    Beta Agonists, Asthma, Albuterol, Levalbuterol

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Albuterol 5 mg first, then levalbuterol 2.5 mg
    Arm Type
    Experimental
    Arm Description
    Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
    Arm Title
    Levalbuterol 2.5 mg first, then albuterol 5 mg
    Arm Type
    Experimental
    Arm Description
    Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
    Intervention Type
    Drug
    Intervention Name(s)
    Albuterol
    Intervention Description
    Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
    Intervention Type
    Drug
    Intervention Name(s)
    Levalbuterol
    Intervention Description
    Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
    Primary Outcome Measure Information:
    Title
    Oxygen Consumption
    Description
    Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
    Time Frame
    0 to 60 minutes
    Secondary Outcome Measure Information:
    Title
    Heart Rate
    Description
    Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
    Time Frame
    0 to 60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers between the ages of 18 and 60 years Exclusion Criteria: Coronary artery disease, history of intolerance to beta agonists
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick A Ross, MD
    Organizational Affiliation
    Children's Hospital Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

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