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

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ClinicalTrials.gov Identifier: NCT00325767
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : May 15, 2006
Sponsor:
Collaborator:
Sunovion
Information provided by:
Johns Hopkins University

Study Description
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Brief 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.

Condition or disease Intervention/treatment 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 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
Study Start Date : May 2004
Study Completion Date : September 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Lung mucociliary clearance
  2. Lung cough clearance

Secondary Outcome Measures :
  1. Forced expiratory volume in 1 second
  2. Forced vital capacity

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325767


Locations
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United States, Maryland
Eudowood Division of Pediatric Respiratory Sciences
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Sunovion
Investigators
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Study Director: Beth L Laube, Ph.D. Johns Hopkins University
Principal Investigator: Jeffrey C Cleary, M.D. Johns Hopkins University
More Information
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ClinicalTrials.gov Identifier: NCT00325767    
Other Study ID Numbers: RPN 04-03-19-11
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: May 15, 2006
Last Verified: April 2006
Keywords provided by Johns Hopkins University:
mucociliary clearance
beta-adrenergic drugs
inhalation
aerosol
Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
 Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action