Inflammatory Markers in Sputum After LPS Inhalation

Not Applicable

• Conditions: Inflammation
• Interventions: Biological: LPS

• Registration Number: NCT01081392
• Lead Sponsor: Centre Hospitalier Universitaire Brugmann

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-04
• Last Update Submitted: 2010-03-04
• Study First Posted: 2010-03-05
• Last Update Posted: 2010-03-05
• Primary Completion: 2010-04
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LPS sequence 5	LPS	Nebulizers C then B then A
LPS sequence 6	LPS	Nebulizers B then A then C
LPS sequence 2	LPS	Nebulizers B then C then A
LPS sequence 4	LPS	Nebulizers A then C then B
LPS sequence 1	LPS	Nebulizers A then B then C
LPS sequence 3	LPS	Nebulizers C then A then B

Primary Outcome Measures

Name	Time	Method
Absolute neutrophil count in sputum	24hrs after LPS inhalation

Secondary Outcome Measures

Name	Time	Method
CRP in peripheral blood	0, 6 and 24hrs after LPS inhalation
Alveolo-capillary diffusion	0, 6 and 24hrs after LPS inhalation
12-lead ECG	Screening Visit 1 and final Visit 5
Calgranulin A/B	0, 6 and 24hrs after LPS inhalation
Safety labs from peripheral blood	At the Screening Visit 1 and the Final Visit 5	hematology, blood chemistry (ionogram, AST, ALT, alkaline phosphatases, urea, creatinine)
white blood cells and differential in peripheral blood	0, 6 and 24 hrs after LPS inhalation
CC16 in peripheral blood	0, 6 and 24hrs after LPS inhalation
Physical exam	At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit	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
Spirometry (FEV1 and FEV1/FEV)	0, 1, 6 and 24hrs after LPS inhalation

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium