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OpenTrials
Completed

NCT Number: NCT00325767

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eudowood Division of Pediatric Respiratory Sciences

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebulized albuterol (2.5 mg/3ml/dose)

Drug

nebulized levalbuterol (1.25 mg/3ml/dose)

Drug

nebulized placebo (3ml/dose)

Drug

Primary outcomes

  1. Lung mucociliary clearance

  2. Lung cough clearance

Secondary outcomes

  1. Forced expiratory volume in 1 second

  2. Forced vital capacity

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Sumitomo Pharma America, Inc.

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
May 15, 2006
Registry last updated
May 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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