Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol - Full Text View

Sponsor:	Johns Hopkins University
Collaborator:	Sepracor, Inc.
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00325767

Purpose

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.

Condition	Intervention	Phase
Mucociliary Clearance	Drug: nebulized albuterol (2.5 mg/3ml/dose) Drug: nebulized levalbuterol (1.25 mg/3ml/dose) Drug: nebulized placebo (3ml/dose)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol

Resource links provided by NLM:

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Lung mucociliary clearance
Lung cough clearance

Secondary Outcome Measures:

Forced expiratory volume in 1 second
Forced vital capacity

Estimated Enrollment:	10
Study Start Date:	May 2004
Estimated Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325767

Locations

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

Sponsors and Collaborators

Johns Hopkins University

Sepracor, Inc.

Investigators

Study Director:	Beth L Laube, Ph.D.	Johns Hopkins Medical Institutions
Principal Investigator:	Jeffrey C Cleary, M.D.	Johns Hopkins Medical Institutions

More Information

No publications provided

Study ID Numbers:	RPN 04-03-19-11
Study First Received:	May 12, 2006
Last Updated:	May 12, 2006
ClinicalTrials.gov Identifier:	NCT00325767 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

mucociliary clearance
beta-adrenergic drugs
inhalation
aerosol

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Albuterol
Physiological Effects of Drugs
Anti-Asthmatic Agents

Reproductive Control Agents
Pharmacologic Actions
Adrenergic Agonists
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009