Inflammatory Markers in Sputum After LPS Inhalation

Centre Hospitalier Universitaire Brugmann12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Inflammation

Interventions

LPSBIOLOGICAL

LPS 20mcg sd inhaled via nebulizer, 3 periods

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: * infection within 14 days * history of bronchial asthma * obstructive respiratory condition with FEV1 \<70% of theoretical value

Locations (1)

CHU Brugmann

Brussels, Belgium

Outcomes

Primary Outcomes

Absolute neutrophil count in sputum

Time frame: 24hrs after LPS inhalation

Secondary Outcomes

white blood cells and differential in peripheral blood

Time frame: 0, 6 and 24 hrs after LPS inhalation

CC16 in peripheral blood

Time frame: 0, 6 and 24hrs after LPS inhalation

Calgranulin A/B

Time frame: 0, 6 and 24hrs after LPS inhalation

CRP in peripheral blood

Time frame: 0, 6 and 24hrs after LPS inhalation

Spirometry (FEV1 and FEV1/FEV)

Time frame: 0, 1, 6 and 24hrs after LPS inhalation

Alveolo-capillary diffusion

Time frame: 0, 6 and 24hrs after LPS inhalation

12-lead ECG

Time frame: Screening Visit 1 and final Visit 5

Physical exam

A complete physical exam at screening and at the final Visits, and an abbreviated physical exam at the three Visits during which LPS will be administered

Time frame: At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit

Safety labs from peripheral blood

hematology, blood chemistry (ionogram, AST, ALT, alkaline phosphatases, urea, creatinine)

Time frame: At the Screening Visit 1 and the Final Visit 5

Data from ClinicalTrials.gov

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