An interventional study of Albuterol and Levalbuterol in Oxygen Consumption, sponsored by Children's Hospital Los Angeles. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Basic science
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
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 215 are open to participants now.
This study's enrollment of 24 is below the median of 43 across 882 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
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.
Drug: Albuterol
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.
Drug: Levalbuterol
Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
Oxygen Consumption
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
Time frame: 0 to 60 minutes
Heart Rate
Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
Time frame: 0 to 60 minutes
| Milestone | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
| Milestone | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
| Milestone | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
| mls/kg/min | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg |
|---|---|---|
| Oxygen Consumption | .28 (.15 to .36) | .27 (.19 to .35) |
Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
| beats per minute | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg |
|---|---|---|
| Heart Rate | 91 (84 to 103) | 93 (87 to 102) |
Collected over We observed the volunteers over 4 hours following use of either albuterol first or levalbuterol first then for another 4 hours following the second medication.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albuterol 5 mg First, Then Levalbuterol 2.5 mg | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Levalbuterol 2.5 mg First, Then Albuterol 5 mg | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 12 | 24 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Total |
|---|---|---|---|
| Median | 30 (19 to 40) | 34 (24 to 53) | 32 (19 to 53) |
| Sex: Female, Male(Participants) | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 6 | 7 | 13 |
| Race (NIH/OMB)(Participants) | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 2 | 2 | 4 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 6 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Albuterol 5 mg First, Then Levalbuterol 2.5 mg | Levalbuterol 2.5 mg First, Then Albuterol 5 mg | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
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