Oxygen Consumption
Conditions
Keywords
Beta Agonists, Asthma, Albuterol, Levalbuterol
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.
Interventions
DRUGAlbuterol
Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
DRUGLevalbuterol
Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers between the ages of 18 and 60 years
Exclusion criteria
* Coronary artery disease, history of intolerance to beta agonists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Consumption | 0 to 60 minutes | Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 0 to 60 minutes | Vital signs including heart rate will be measured for up to 60 minutes following beta agonist |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Albuterol 5 mg First, Then Levalbuterol 2.5 mg 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.
Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. | 12 |
| Levalbuterol 2.5 mg First, Then Albuterol 5 mg 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.
Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Total | Albuterol 5 mg First, Then Levalbuterol 2.5 mg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 24 Participants | 12 Participants |
| Age, Continuous | 34 years | 32 years | 30 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 4 Participants |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Oxygen Consumption
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
Time frame: 0 to 60 minutes
Population: Healthy volunteers, median age 32 years. The population is 24 individuals they are randomized to which bronchodilator they received first. Half were randomized to Albuterol and half to levalbuterol but each subject received both medication. It is a matter of which they received first. There was a four hour wash out period between the first and second medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Oxygen Consumption | .28 mls/kg/min |
| Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Oxygen Consumption | .27 mls/kg/min |
Secondary
Heart Rate
Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
Time frame: 0 to 60 minutes
Population: Healthy volunteers, median age 32 years. The population is 24 individuals they are randomized to which bronchodilator they received first. Half were randomized to Albuterol and half to levalbuterol but each subject received both medication. It is a matter of which they received first. There was a four hour wash out period between the first and second medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Heart Rate | 91 beats per minute |
| Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Heart Rate | 93 beats per minute |