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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00325767
Enrollment
10
Registered
2006-05-15
Start date
2004-05-31
Completion date
2005-09-30
Last updated
2006-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucociliary Clearance

Keywords

mucociliary clearance, beta-adrenergic drugs, inhalation, aerosol

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.

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.

Interventions

DRUGnebulized albuterol (2.5 mg/3ml/dose)
DRUGnebulized levalbuterol (1.25 mg/3ml/dose)
DRUGnebulized placebo (3ml/dose)

Sponsors

Sumitomo Pharma America, Inc.
CollaboratorINDUSTRY
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Lung mucociliary clearance
Lung cough clearance

Secondary

MeasureTime frame
Forced expiratory volume in 1 second
Forced vital capacity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026