Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Children's Hospital Los Angeles

Status: Completed

Conditions: Oxygen Consumption

Treatments: Drug: Levalbuterol; Drug: Albuterol

Study type: Interventional

Funder types: Other

Identifiers

NCT02802111

CCI-14-00101

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Albuterol 5 mg first, then levalbuterol 2.5 mg

Experimental group

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.

Treatment:

Drug: Albuterol

Levalbuterol 2.5 mg first, then albuterol 5 mg

Experimental group

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.

Treatment:

Drug: Levalbuterol