Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02802111
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2016-06-10
Brief Title:
Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison With Levalbuterol in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 VO2 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 VO2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None