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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPS sequence 1 | Experimental | Nebulizers A then B then C |
|
| LPS sequence 2 | Experimental | Nebulizers B then C then A |
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| LPS sequence 3 | Experimental | Nebulizers C then A then B |
|
| LPS sequence 4 | Experimental | Nebulizers A then C then B |
|
| LPS sequence 5 | Experimental | Nebulizers C then B then A |
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| LPS sequence 6 | Experimental | Nebulizers B then A then C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPS | Biological | LPS 20mcg sd inhaled via nebulizer, 3 periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute neutrophil count in sputum | 24hrs after LPS inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Calgranulin A/B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier MICHEL, MD, PhD | CHU Brugmann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann | Brussels | 1020 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27331367 | Derived | Doyen V, Pilcer G, Dinh PH, Corazza F, Bernard A, Bergmann P, Lefevre N, Amighi K, Michel O. Inflammation induced by inhaled lipopolysaccharide depends on particle size in healthy volunteers. Br J Clin Pharmacol. 2016 Nov;82(5):1371-1381. doi: 10.1111/bcp.13052. Epub 2016 Jul 28. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 0, 6 and 24hrs after LPS inhalation |
| CRP in peripheral blood | 0, 6 and 24hrs after LPS inhalation |
| Spirometry (FEV1 and FEV1/FEV) | 0, 1, 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 |
| 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 | 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) | At the Screening Visit 1 and the Final Visit 5 |