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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mucociliary Clearance

Intervention / Treatment
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* Drug: nebulized albuterol (2.5 mg/3ml/dose)
* Drug: nebulized levalbuterol (1.25 mg/3ml/dose)
* Drug: nebulized placebo (3ml/dose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nebulized albuterol (2.5 mg/3ml/dose)|nan|
|Drug: nebulized levalbuterol (1.25 mg/3ml/dose)|nan|
|Drug: nebulized placebo (3ml/dose)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung mucociliary clearance |  |  | 
| Lung cough clearance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second |  |  | 
| Forced vital capacity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucociliary clearance, beta-adrenergic drugs, inhalation, aerosol