NCT00325767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
Last Updated

May 15, 2006

Status Verified

April 1, 2006

First QC Date

May 12, 2006

Last Update Submit

May 12, 2006

Conditions

Mucociliary Clearance

Keywords

mucociliary clearancebeta-adrenergic drugsinhalationaerosol

Outcome Measures

Primary Outcomes (2)

  • Lung mucociliary clearance

  • Lung cough clearance

Secondary Outcomes (2)

  • Forced expiratory volume in 1 second

  • Forced vital capacity

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eudowood Division of Pediatric Respiratory Sciences

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Beth L Laube, Ph.D.

    Johns Hopkins University

    STUDY DIRECTOR

  • Jeffrey C Cleary, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

May 1, 2004

Study Completion

September 1, 2005

Last Updated

May 15, 2006

Record last verified: 2006-04

Locations

US(1)