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
About this trial
This is an interventional basic science trial for Oxygen Consumption focused on measuring Beta Agonists, Asthma, Albuterol, Levalbuterol
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
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
NCT ID
NCT02802111
First Posted
June 10, 2016
Last Updated
October 7, 2020
Sponsor
Children's Hospital Los Angeles
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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