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

NCT ID: NCT00325767

Last Updated: 2006-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-09-30

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.

Conditions

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Mucociliary Clearance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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nebulized albuterol (2.5 mg/3ml/dose)

Intervention Type DRUG

nebulized levalbuterol (1.25 mg/3ml/dose)

Intervention Type DRUG

nebulized placebo (3ml/dose)

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Principal Investigators

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Beth L Laube, Ph.D.

Role: STUDY_DIRECTOR

Johns Hopkins University

Jeffrey C Cleary, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Eudowood Division of Pediatric Respiratory Sciences

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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RPN 04-03-19-11

Identifier Type: -

Identifier Source: org_study_id