Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

• Sponsor: Children's Hospital Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT02802111
• Collaborator: (none)
• Enrollment: 24
• Arms: 2
• Duration (Months): 27

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oxygen Consumption	Drug: Albuterol; Drug: Levalbuterol	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Albuterol; Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Experimental: 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.	Drug: Levalbuterol; Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention

Outcome Measures

Primary Outcome Measures

1. Oxygen Consumption [0 to 60 minutes]

   Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol

Secondary Outcome Measures

1. Heart Rate [0 to 60 minutes]

   Vital signs including heart rate will be measured for up to 60 minutes following beta agonist

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Hospital Los Angeles

Investigators

• Principal Investigator: Patrick A Ross, MD, Children's Hospital Los Angeles

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 18, 2014

More Information

Publications

None provided.

• Responsible Party: Patrick Ross, Associate Professor of Clinical Anesthesia and Pediatrics, Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT02802111
• Other Study ID Numbers: CCI-14-00101
• First Posted: Jun 16, 2016
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Patrick Ross, Associate Professor of Clinical Anesthesia and Pediatrics, Children's Hospital Los Angeles: Beta Agonists; Asthma; Albuterol; Levalbuterol
• Additional relevant MeSH terms: Respiratory Aspiration; Albuterol

Study Results

Participant Flow

Arm/Group Title	Albuterol 5 mg First, Then Levalbuterol 2.5 mg	Levalbuterol 2.5 mg First, Then Albuterol 5 mg
Arm/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. Albuterol: 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 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
Period Title: First Intervention (5 Min of Drug)
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0
Period Title: First Intervention (5 Min of Drug)
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0
Period Title: First Intervention (5 Min of Drug)
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Albuterol 5 mg First, Then Levalbuterol 2.5 mg	Levalbuterol 2.5 mg First, Then Albuterol 5 mg	Total
Arm/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. Albuterol: 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 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	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	30	34	32
Sex: Female, Male (Count of Participants)
Female	6 50%	5 41.7%	11 45.8%
Male	6 50%	7 58.3%	13 54.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 50%	4 33.3%	10 41.7%
Native Hawaiian or Other Pacific Islander	2 16.7%	2 16.7%	4 16.7%
Black or African American	0 0%	0 0%	0 0%
White	4 33.3%	6 50%	10 41.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Oxygen Consumption
Description	Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
Time Frame	0 to 60 minutes

Outcome Measure Data

Analysis Population Description

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/Group Title	Albuterol 5 mg First, Then Levalbuterol 2.5 mg	Levalbuterol 2.5 mg First, Then Albuterol 5 mg
Arm/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. Albuterol: 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 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
Measure Participants	24	24
Median (Inter-Quartile Range) [mls/kg/min]	.28	.27

2. Secondary Outcome

Title	Heart Rate
Description	Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
Time Frame	0 to 60 minutes

Outcome Measure Data

Analysis Population Description

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/Group Title	Albuterol 5 mg First, Then Levalbuterol 2.5 mg	Levalbuterol 2.5 mg First, Then Albuterol 5 mg
Arm/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. Albuterol: 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 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
Measure Participants	24	24
Median (Inter-Quartile Range) [beats per minute]	91	93

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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. If there were an adverse event we would record it in the area for the first medication that they received. Overall there were no adverse events.
Arm/Group Title	Albuterol 5 mg First, Then Levalbuterol 2.5 mg		Levalbuterol 2.5 mg First, Then Albuterol 5 mg
Arm/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. Patients are observed for adverse events for 4 hours after second medication. Albuterol: 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 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. Patients are observed for adverse events for 4 hours after second medication. Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
All Cause Mortality
	Albuterol 5 mg First, Then Levalbuterol 2.5 mg		Levalbuterol 2.5 mg First, Then Albuterol 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Albuterol 5 mg First, Then Levalbuterol 2.5 mg		Levalbuterol 2.5 mg First, Then Albuterol 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Albuterol 5 mg First, Then Levalbuterol 2.5 mg		Levalbuterol 2.5 mg First, Then Albuterol 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.