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

March 2, 2010
March 4, 2010
January 2010
April 2010   (final data collection date for primary outcome measure)
Absolute neutrophil count in sputum [ Time Frame: 24hrs after LPS inhalation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081392 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Inflammatory Markers in Sputum After LPS Inhalation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Inflammation
Biological: LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods
  • Experimental: LPS sequence 1
    Nebulizers A then B then C
    Intervention: Biological: LPS
  • Experimental: LPS sequence 2
    Nebulizers B then C then A
    Intervention: Biological: LPS
  • Experimental: LPS sequence 3
    Nebulizers C then A then B
    Intervention: Biological: LPS
  • Experimental: LPS sequence 4
    Nebulizers A then C then B
    Intervention: Biological: LPS
  • Experimental: LPS sequence 5
    Nebulizers C then B then A
    Intervention: Biological: LPS
  • Experimental: LPS sequence 6
    Nebulizers B then A then C
    Intervention: Biological: LPS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01081392
CIA-01.2
No
Jean-Pierre Tassignon, MD, PhD, Head Clinical Research Unit, CHU Brugmann
Centre Hospitalier Universitaire Brugmann
Not Provided
Principal Investigator: Olivier MICHEL, MD, PhD CHU Brugmann
Centre Hospitalier Universitaire Brugmann
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP