Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Not Applicable

Completed

• Conditions: Oxygen Consumption
• Interventions: Drug: Albuterol; Drug: Levalbuterol

• Registration Number: NCT02802111
• Lead Sponsor: Children's Hospital Los Angeles

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-16
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2019-07-22
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Results First Posted: 2020-10-28
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria

• Coronary artery disease, history of intolerance to beta agonists

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Albuterol 5 mg first, then levalbuterol 2.5 mg	Albuterol	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.
Levalbuterol 2.5 mg first, then albuterol 5 mg	Levalbuterol	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.

Primary Outcome Measures

Name	Time	Method
Oxygen Consumption	0 to 60 minutes	Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol

Secondary Outcome Measures

Name	Time	Method
Heart Rate	0 to 60 minutes	Vital signs including heart rate will be measured for up to 60 minutes following beta agonist