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

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00325767
First received: May 12, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sunovion
Investigators
Study Director: Beth L Laube, Ph.D. Johns Hopkins University
Principal Investigator: Jeffrey C Cleary, M.D. Johns Hopkins University
  More Information

No publications provided

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

Keywords provided by Johns Hopkins University:
mucociliary clearance
beta-adrenergic drugs
inhalation
aerosol

Additional relevant MeSH terms:
Albuterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 20, 2014