NCT00325767

Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mucociliary Clearance

Interventions

Type	Name	Description
DRUG	nebulized albuterol (2.5 mg/3ml/dose)
DRUG	nebulized levalbuterol (1.25 mg/3ml/dose)
DRUG	nebulized placebo (3ml/dose)

Timeline

• Start date: 2004-05-01
• Completion: 2005-09-01
• First posted: 2006-05-15
• Last updated: 2006-05-15

Locations

1 site across 1 country: United States