NCT01081392

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 5, 2010

Status Verified

March 1, 2010

Enrollment Period

3 months

First QC Date

March 2, 2010

Last Update Submit

March 4, 2010

Conditions

Inflammation

Keywords

LPSendotoxininflammatory markershealthy volunteersneutrophils in sputum

Outcome Measures

Primary Outcomes (1)

  • Absolute neutrophil count in sputum

    24hrs after LPS inhalation

Secondary Outcomes (9)

  • 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

    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

  • +4 more secondary outcomes

Study Arms (6)

LPS sequence 1

EXPERIMENTAL

Nebulizers A then B then C

Biological: LPS

LPS sequence 2

EXPERIMENTAL

Nebulizers B then C then A

Biological: LPS

LPS sequence 3

EXPERIMENTAL

Nebulizers C then A then B

Biological: LPS

LPS sequence 4

EXPERIMENTAL

Nebulizers A then C then B

Biological: LPS

LPS sequence 5

EXPERIMENTAL

Nebulizers C then B then A

Biological: LPS

LPS sequence 6

EXPERIMENTAL

Nebulizers B then A then C

Biological: LPS

Interventions

LPSBIOLOGICAL

LPS 20mcg sd inhaled via nebulizer, 3 periods

LPS sequence 1LPS sequence 2LPS sequence 3LPS sequence 4LPS sequence 5LPS sequence 6

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • infection within 14 days
  • history of bronchial asthma
  • obstructive respiratory condition with FEV1 \<70% of theoretical value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 27331367DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier MICHEL, MD, PhD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 5, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

March 5, 2010

Record last verified: 2010-03

Locations

BE(1)