Inflammatory Markers in Sputum After LPS Inhalation

March 4, 2010 updated by: Centre Hospitalier Universitaire Brugmann

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LPS sequence 1
Nebulizers A then B then C
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods
EXPERIMENTAL: LPS sequence 2
Nebulizers B then C then A
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods
EXPERIMENTAL: LPS sequence 3
Nebulizers C then A then B
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods
EXPERIMENTAL: LPS sequence 4
Nebulizers A then C then B
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods
EXPERIMENTAL: LPS sequence 5
Nebulizers C then B then A
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods
EXPERIMENTAL: LPS sequence 6
Nebulizers B then A then C
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute neutrophil count in sputum
Time Frame: 24hrs after LPS inhalation
24hrs after LPS inhalation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Brugmann

Investigators

  • Principal Investigator: Olivier MICHEL, MD, PhD, CHU Brugmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2010

Study Completion (ANTICIPATED)

May 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (ESTIMATE)

March 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2010

Last Update Submitted That Met QC Criteria

March 4, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-01.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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