Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325767
Status:
COMPLETED
Last Update Posted:
2006-05-15
First Post:
2006-05-12
Brief Title:
Mucociliary Clearance in Healthy Subjects Comparison of Levalbuterol and Racemic Albuterol
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Mucociliary Clearance in Healthy Subjects Comparison of Levalbuterol and Racemic Albuterol
Status:
COMPLETED
Status Verified Date:
2006-04
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:
The purpose of this study is to determine whether lung mucociliary clearance MCC can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol as compared to racemic albuterol or placebo Subjects will inhale one week of levalbuterol one week of racemic albuterol and one week of placebo in a randomized order
Detailed Description:
In healthy lungs inhaled insoluble material such as bacteria viruses antigens and toxins deposit in the tracheobronchial airway mucus and are removed from the lung in a matter of hours by mucociliary clearance MCC When MCC is overwhelmed or impaired some mucus can be removed by mechanical or cough clearance CC Impairment of MCC typically leads to the accumulation of mucus in the airways and this in turn is associated with acute infections chronic bacterial colonization and chronic inflammation
Racemic albuterol has been shown to stimulate MCC in various patient populations Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects
Racemic albuterol has been shown to stimulate MCC in various patient populations Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects
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