Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-08-31

Brief Summary

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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).

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Detailed Description

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Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. This practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bronchodilation. However, the acute inhibition of adrenergic agonist disposal by the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by locally released norepinephrine thereby decongesting the airway wall, and potentiate the bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the same mechanism. The purpose of this study is to assess the vasoconstrictive effects of single and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use inhaled glucocorticosteroids regularly. As a secondary endpoint, airway inflammation and airway function will also be measured with the expectation that acute improvements in airflow might be detectable as a result of airway decongestion, notably in subjects with moderately severe asthma who have lower baseline lung function.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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budesonide 360ug

asthmatic subject received different doses of inhaled budesonide in random other

Group Type EXPERIMENTAL

Budesonide 360ug

Intervention Type DRUG

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

budesonide 720ug

asthmatic subject received different doses of inhaled budesonide in random other

Group Type EXPERIMENTAL

Budesonide 720ug

Intervention Type DRUG

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

budesonide 1440ug

asthmatic subject received different doses of inhaled budesonide in random other

Group Type EXPERIMENTAL

Budesonide 1440ug

Intervention Type DRUG

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

placebo

asthmatic subject received inhaled placebo

Group Type PLACEBO_COMPARATOR

Budesonide720ug 4 times

Intervention Type DRUG

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

Budesonide720ug 4 times

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

A single inhaled dose of placebo from a DPI.

Interventions

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Budesonide 360ug

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

Intervention Type DRUG

Budesonide 720ug

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

Intervention Type DRUG

Budesonide 1440ug

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

Intervention Type DRUG

Budesonide720ug 4 times

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

Intervention Type DRUG

Placebo

A single inhaled dose of placebo from a DPI.

Intervention Type DRUG

Other Intervention Names

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Pulmicort Flexhaler Pulmicort Flexhaler Pulmicort Flexhaler Pulmicort Flexhaler sugar pill

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No