Inflammatory Markers in Sputum After LPS Inhalation

Centre Hospitalier Universitaire Brugmann

Status: Unknown

Conditions: Inflammation

Treatments: Biological: LPS

Study type: Interventional

Funder types: Other

Identifiers

NCT01081392

CIA-01.2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 6 patient groups

LPS sequence 1

Experimental group

Description:

Nebulizers A then B then C

Treatment:

Biological: LPS

LPS sequence 2

Experimental group

Description:

Nebulizers B then C then A

Treatment:

Biological: LPS

LPS sequence 3

Experimental group

Description:

Nebulizers C then A then B

Treatment:

Biological: LPS

LPS sequence 4

Experimental group

Description:

Nebulizers A then C then B

Treatment:

Biological: LPS

LPS sequence 5

Experimental group

Description:

Nebulizers C then B then A

Treatment:

Biological: LPS

LPS sequence 6

Experimental group

Description:

Nebulizers B then A then C

Treatment:

Biological: LPS