NCT02802111

Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oxygen Consumption

Interventions

Type	Name	Description
DRUG	Albuterol	Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
DRUG	Levalbuterol	Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-06-16
• Last updated: 2020-10-28
• Results posted: 2020-10-28