Inflammatory Markers in Sputum After LPS Inhalation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as particles of different sizes.

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Detailed Description

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Endotoxins are inflammatory substances present in the environment. In man, the inhalation of the lipopolysaccharride moiety (LPS) induces measurable immune responses. With an inhaled single dose of 20 micron, the inflammatory response in man is sub-clinical. During bronchoprovocation tests with allergens, the particle size determines to a large extent the intensity of the response. the response to LPS as a function of particle size is not known and will be studied in this study.

Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Intervention Type BIOLOGICAL

LPS 20mcg sd inhaled via nebulizer, 3 periods

Interventions

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LPS

LPS 20mcg sd inhaled via nebulizer, 3 periods

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* healthy volunteer, non-smoking or ex-smoker \>1mth and \<10packs/year
* normal ECG
* normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP
* FEV1/forced vital capacity \>0.7 and FEV1\>80% of predicted value
* able to produce valid sputum following induction (\>=50% viable cells, \<50% squamous cells and \<60% neutrophils)
* females must be using contraception
* written informed consent