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Inflammatory Markers in Sputum After LPS Inhalation

Primary Purpose

Inflammation

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

LPS

About this trial

This is an interventional basic science trial for Inflammation focused on measuring LPS, endotoxin, inflammatory markers, healthy volunteers, neutrophils in sputum

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

LPS sequence 1

LPS sequence 2

LPS sequence 3

LPS sequence 4

LPS sequence 5

LPS sequence 6

Arm Description

Nebulizers A then B then C

Nebulizers B then C then A

Nebulizers C then A then B

Nebulizers A then C then B

Nebulizers C then B then A

Nebulizers B then A then C

Outcomes

Primary Outcome Measures

Absolute neutrophil count in sputum

Secondary Outcome Measures

white blood cells and differential in peripheral blood

CC16 in peripheral blood

Calgranulin A/B

CRP in peripheral blood

Spirometry (FEV1 and FEV1/FEV)

Alveolo-capillary diffusion

12-lead ECG

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

Safety labs from peripheral blood

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

Full Information

NCT ID

NCT01081392

First Posted

March 2, 2010

Last Updated

March 4, 2010

Sponsor

Centre Hospitalier Universitaire Brugmann

1. Study Identification

Unique Protocol Identification Number

NCT01081392

Brief Title

Inflammatory Markers in Sputum After LPS Inhalation

Official Title

The Role of Inhaled Particle Size on the Inflammatory Response Induced by Endotoxin Inhalation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Centre Hospitalier Universitaire Brugmann

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation

Keywords

LPS, endotoxin, inflammatory markers, healthy volunteers, neutrophils in sputum

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LPS sequence 1

Arm Type

Experimental

Arm Description

Nebulizers A then B then C

Arm Title

LPS sequence 2

Arm Type

Experimental

Arm Description

Nebulizers B then C then A

Arm Title

LPS sequence 3

Arm Type

Experimental

Arm Description

Nebulizers C then A then B

Arm Title

LPS sequence 4

Arm Type

Experimental

Arm Description

Nebulizers A then C then B

Arm Title

LPS sequence 5

Arm Type

Experimental

Arm Description

Nebulizers C then B then A

Arm Title

LPS sequence 6

Arm Type

Experimental

Arm Description

Nebulizers B then A then C

Intervention Type

Biological

Intervention Name(s)

LPS

Intervention Description

LPS 20mcg sd inhaled via nebulizer, 3 periods

Primary Outcome Measure Information:

Title

Absolute neutrophil count in sputum

Time Frame

24hrs after LPS inhalation

Secondary Outcome Measure Information:

Title

white blood cells and differential in peripheral blood

Time Frame

0, 6 and 24 hrs after LPS inhalation

Title

CC16 in peripheral blood

Time Frame

0, 6 and 24hrs after LPS inhalation

Title

Calgranulin A/B

Time Frame

0, 6 and 24hrs after LPS inhalation

Title

CRP in peripheral blood

Time Frame

0, 6 and 24hrs after LPS inhalation

Title

Spirometry (FEV1 and FEV1/FEV)

Time Frame

0, 1, 6 and 24hrs after LPS inhalation

Title

Alveolo-capillary diffusion

Time Frame

0, 6 and 24hrs after LPS inhalation

Title

12-lead ECG

Time Frame

Screening Visit 1 and final Visit 5

Title

Physical exam

Description

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

Title

Safety labs from peripheral blood

Description

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

Time Frame

At the Screening Visit 1 and the Final Visit 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier MICHEL, MD, PhD

Organizational Affiliation

CHU Brugmann

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Brugmann

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

27331367

Citation

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.

Results Reference

derived

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Inflammatory Markers in Sputum After LPS Inhalation

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