Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
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.
Drug: nebulized albuterol (2.5 mg/3ml/dose)
Drug: nebulized levalbuterol (1.25 mg/3ml/dose)
Drug: nebulized placebo (3ml/dose)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol|
- Lung mucociliary clearance
- Lung cough clearance
- Forced expiratory volume in 1 second
- Forced vital capacity
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||September 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325767
|United States, Maryland|
|Eudowood Division of Pediatric Respiratory Sciences|
|Baltimore, Maryland, United States, 21287|
|Study Director:||Beth L Laube, Ph.D.||Johns Hopkins University|
|Principal Investigator:||Jeffrey C Cleary, M.D.||Johns Hopkins University|