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

Mucociliary Clearance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325767
• Other study ID #: RPN 04-03-19-11
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2006
• Last updated: May 12, 2006
• Start date: May 2004
• Est. completion date: September 2005

Study information

• Verified date: April 2006
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucociliary Clearance

Intervention

Drug:
• nebulized albuterol (2.5 mg/3ml/dose)

• nebulized levalbuterol (1.25 mg/3ml/dose)

• nebulized placebo (3ml/dose)

Locations

Country	Name	City	State
United States	Eudowood Division of Pediatric Respiratory Sciences	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung mucociliary clearance
Primary	Lung cough clearance
Secondary	Forced expiratory volume in 1 second
Secondary	Forced vital capacity