Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide

NCT01219738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-01-16

Study results available
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Summary

Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).

Conditions

Interventions

DRUG

Budesonide 360ug

A single inhaled dose of 360ug budesonide from a DPI.

DRUG

Budesonide 720ug

A single inhaled dose of 720ug budesonide from a DPI.

DRUG

Budesonide 1440ug

A single dose of 1440ug of the budesonide from DPI.

DRUG

Budesonide720ug 4 times

720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.

DRUG

Placebo

A single inhaled dose of placebo from a DPI.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • University of Miami

    lead OTHER

Principal Investigators

  • Eliana Mendes, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219738 on ClinicalTrials.gov