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

Condition(s) targeted: Mucociliary Clearance

Intervention: nebulized albuterol (2.5 mg/3ml/dose) (Drug); nebulized levalbuterol (1.25 mg/3ml/dose) (Drug); nebulized placebo (3ml/dose) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Beth L Laube, Ph.D., Study Director, Affiliation: Johns Hopkins Medical Institutions
Jeffrey C Cleary, M.D., Principal Investigator, Affiliation: Johns Hopkins Medical Institutions

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacodynamics Study

Primary outcome:

Lung mucociliary clearance

Lung cough clearance

Secondary outcome:

Forced expiratory volume in 1 second

Forced vital capacity

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- non-smoking males and non-pregnant females greater than or equal to 18 years of age

- forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater

than or equal to 80% of predicted values

- normal systolic and diastolic blood pressures

Exclusion Criteria:

- history of heart disease, irregular heartbeat, hypertension

- history of diabetes, hyperthyroid

- history of pneumonia, tuberculosis

- history of seizure disorder, depression, hospitalization in the last month for

non-elective purposes, cold or flu in the previous three months

Eudowood Division of Pediatric Respiratory Sciences, Baltimore, Maryland 21287, United States

Starting date: May 2004
Ending date: September 2005
Last updated: May 12, 2006