N/A N=20 Randomized Double-blind Basic Science

Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01219738 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Airway Blood Flow (Qaw) — 22.3; 29.4; 34.1; 28.2 percentage of change from baseline

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Budesonide 360ug (Drug); Budesonide 720ug (Drug); Budesonide 1440ug (Drug); Budesonide720ug 4 times (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Airway Blood Flow (Qaw)	22.3; 29.4; 34.1; 28.2; 5.1	—
SECONDARY Forced Expiratory Volume in 1 Second (FEV1)	0.1; 3.2; 1.6; 3.2; 0.8	—

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).

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01219738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.