Inflammatory Markers in Sputum After LPS Inhalation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Centre Hospitalier Universitaire Brugmann.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Brugmann
ClinicalTrials.gov Identifier:
NCT01081392
First received: March 2, 2010
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Inflammation
Biological: LPS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Role of Inhaled Particle Size on the Inflammatory Response Induced by Endotoxin Inhalation

Further study details as provided by Centre Hospitalier Universitaire Brugmann:

Primary Outcome Measures:
  • Absolute neutrophil count in sputum [ Time Frame: 24hrs after LPS inhalation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • white blood cells and differential in peripheral blood [ Time Frame: 0, 6 and 24 hrs after LPS inhalation ] [ Designated as safety issue: No ]
  • CC16 in peripheral blood [ Time Frame: 0, 6 and 24hrs after LPS inhalation ] [ Designated as safety issue: No ]
  • Calgranulin A/B [ Time Frame: 0, 6 and 24hrs after LPS inhalation ] [ Designated as safety issue: No ]
  • CRP in peripheral blood [ Time Frame: 0, 6 and 24hrs after LPS inhalation ] [ Designated as safety issue: No ]
  • Spirometry (FEV1 and FEV1/FEV) [ Time Frame: 0, 1, 6 and 24hrs after LPS inhalation ] [ Designated as safety issue: Yes ]
  • Alveolo-capillary diffusion [ Time Frame: 0, 6 and 24hrs after LPS inhalation ] [ Designated as safety issue: No ]
  • 12-lead ECG [ Time Frame: Screening Visit 1 and final Visit 5 ] [ Designated as safety issue: Yes ]
  • Physical exam [ Time Frame: At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At the Screening Visit 1 and the Final Visit 5 ] [ Designated as safety issue: Yes ]
    hematology, blood chemistry (ionogram, AST, ALT, alkaline phosphatases, urea, creatinine)


Enrollment: 12
Study Start Date: January 2010
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081392

Locations
Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Centre Hospitalier Universitaire Brugmann
Investigators
Principal Investigator: Olivier MICHEL, MD, PhD CHU Brugmann
  More Information

No publications provided

Responsible Party: Jean-Pierre Tassignon, MD, PhD, Head Clinical Research Unit, CHU Brugmann
ClinicalTrials.gov Identifier: NCT01081392     History of Changes
Other Study ID Numbers: CIA-01.2
Study First Received: March 2, 2010
Last Updated: March 4, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Centre Hospitalier Universitaire Brugmann:
LPS
endotoxin
inflammatory markers
healthy volunteers
neutrophils in sputum

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014