NCT01219738

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable asthma

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

July 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

4.1 years

First QC Date

October 12, 2010

Results QC Date

November 12, 2014

Last Update Submit

January 7, 2015

Conditions

Asthma

Keywords

Asthma, airway blood flow, budesonide, glucocorticosteroid.

Outcome Measures

Primary Outcomes (1)

  • Airway Blood Flow (Qaw)

    Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.

    participants will be followed for 6 hours after budesonide dose

Secondary Outcomes (1)

  • Forced Expiratory Volume in 1 Second (FEV1)

    participant will be followed up to 6 hours after budesonide dose

Study Arms (5)

budesonide 360ug

EXPERIMENTAL

asthmatic subject received different doses of inhaled budesonide in random other

Drug: Budesonide 360ug

budesonide 720ug

EXPERIMENTAL

asthmatic subject received different doses of inhaled budesonide in random other

Drug: Budesonide 720ug

budesonide 1440ug

EXPERIMENTAL

asthmatic subject received different doses of inhaled budesonide in random other

Drug: Budesonide 1440ug

placebo

PLACEBO COMPARATOR

asthmatic subject received inhaled placebo

Drug: Budesonide720ug 4 times

Budesonide720ug 4 times

EXPERIMENTAL

asthmatic subject received 720ug of inhaled budesonide 4 times separated by 30 minutes.

Drug: Placebo

Interventions

Budesonide 360ugDRUG

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

Also known as: Pulmicort Flexhaler
budesonide 360ug
Budesonide 720ugDRUG

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

Also known as: Pulmicort Flexhaler
budesonide 720ug
Budesonide 1440ugDRUG

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

Also known as: Pulmicort Flexhaler
budesonide 1440ug
Budesonide720ug 4 timesDRUG

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

Also known as: Pulmicort Flexhaler
placebo
PlaceboDRUG

A single inhaled dose of placebo from a DPI.

Also known as: sugar pill
Budesonide720ug 4 times

Eligibility Criteria

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

You may qualify if:

  • Twenty lifetime nonsmokers moderate or severe asthmatics; FEV1≥50 of predicted on the screening day

You may not qualify if:

  • Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women; Cardiovascular disease and/or use of cardiovascular medication; Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance; Acute respiratory infection and or acute exacerbation of asthma within four weeks prior to the study; Use of systemic glucocorticosteroids within 4 weeks prior to the study; Daily ICS dose (fluticasone or budesonide) \> 500ug; Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Human Research Laboratory, University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (5)

  • Horvath G, Sutto Z, Torbati A, Conner GE, Salathe M, Wanner A. Norepinephrine transport by the extraneuronal monoamine transporter in human bronchial arterial smooth muscle cells. Am J Physiol Lung Cell Mol Physiol. 2003 Oct;285(4):L829-37. doi: 10.1152/ajplung.00054.2003. Epub 2003 Jun 13.

    PMID: 12807698BACKGROUND

  • Horvath G, Lieb T, Conner GE, Salathe M, Wanner A. Steroid sensitivity of norepinephrine uptake by human bronchial arterial and rabbit aortic smooth muscle cells. Am J Respir Cell Mol Biol. 2001 Oct;25(4):500-6. doi: 10.1165/ajrcmb.25.4.4559.

    PMID: 11694456BACKGROUND

  • Mendes ES, Pereira A, Danta I, Duncan RC, Wanner A. Comparative bronchial vasoconstrictive efficacy of inhaled glucocorticosteroids. Eur Respir J. 2003 Jun;21(6):989-93. doi: 10.1183/09031936.03.00072402.

    PMID: 12797493BACKGROUND

  • Brieva JL, Danta I, Wanner A. Effect of an inhaled glucocorticosteroid on airway mucosal blood flow in mild asthma. Am J Respir Crit Care Med. 2000 Jan;161(1):293-6. doi: 10.1164/ajrccm.161.1.9905068.

    PMID: 10619834BACKGROUND

  • Mendes ES, Rebolledo P, Campos M, Wanner A. Immediate antiinflammatory effects of inhaled budesonide in patients with asthma. Ann Am Thorac Soc. 2014 Jun;11(5):706-11. doi: 10.1513/AnnalsATS.201307-220OC.

    PMID: 24735128DERIVED

MeSH Terms

Conditions

Asthma

Interventions

BudesonideSugars

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCarbohydrates

Results Point of Contact

Title
Eliana Mendes
Organization
University of Miami
e.mendes@miami.edu
(305) 243-2568

Study Officials

  • Eliana Mendes, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Miami

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

July 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01

Locations

US(1)