Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Oxygen Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802111
• Other study ID #: CCI-14-00101
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2020
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria:

• Coronary artery disease, history of intolerance to beta agonists

Related Conditions & MeSH terms

• Oxygen Consumption
• Respiratory Aspiration

Intervention

Drug:
• Albuterol
Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
• Levalbuterol
Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption	Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol	0 to 60 minutes
Secondary	Heart Rate	Vital signs including heart rate will be measured for up to 60 minutes following beta agonist	0 to 60 minutes