Inflammatory Markers in Sputum After LPS Inhalation
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Absolute neutrophil count in sputum [ Time Frame: 24hrs after LPS inhalation ] [ Designated as safety issue: No ]
- 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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
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:
Respiratory Aspiration Inflammation Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Pathologic Processes |
ClinicalTrials.gov processed this record on October 17, 2012