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Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02802111
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Patrick Ross, Children's Hospital Los Angeles

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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 : June 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Albuterol
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
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




Primary Outcome Measures :
  1. oxygen consumption [ Time Frame: 0 to 60 minutes ]
    Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: 0 to 60 minutes ]
    Vital signs including heart rate will be measured for up to 60 minutes following beta agonist



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria:

  • Coronary artery disease, history of intolerance to beta agonists

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802111


Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Patrick A Ross, MD Children's Hospital Los Angeles

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Responsible Party: Patrick Ross, Associate Professor of Clinical Anesthesia and Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT02802111     History of Changes
Other Study ID Numbers: CCI-14-00101
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Patrick Ross, Children's Hospital Los Angeles:
Beta Agonists
Asthma
Albuterol
Levalbuterol

Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action