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Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
This study has been completed.
Study NCT00325767   Information provided by Johns Hopkins University
First Received: May 12, 2006   No Changes Posted

May 12, 2006
May 12, 2006
May 2004
 
  • Lung mucociliary clearance
  • Lung cough clearance
Same as current
No Changes Posted
  • Forced expiratory volume in 1 second
  • Forced vital capacity
Same as current
 
Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacodynamics Study
Mucociliary Clearance
  • Drug: nebulized albuterol (2.5 mg/3ml/dose)
  • Drug: nebulized levalbuterol (1.25 mg/3ml/dose)
  • Drug: nebulized placebo (3ml/dose)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
September 2005
 

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00325767
 
RPN 04-03-19-11
Johns Hopkins University
Sepracor, Inc.
Study Director: Beth L Laube, Ph.D. Johns Hopkins Medical Institutions
Principal Investigator: Jeffrey C Cleary, M.D. Johns Hopkins Medical Institutions
Johns Hopkins University
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP