Inflammatory Markers in Sputum After LPS Inhalation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01081392
• Other study ID #: CIA-01.2
• Status: Active, not recruiting
• Phase: N/A
• First received: March 2, 2010
• Last updated: March 4, 2010
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: March 2010
• Source: Centre Hospitalier Universitaire Brugmann
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Biological:
• LPS
LPS 20mcg sd inhaled via nebulizer, 3 periods

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Brugmann

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute neutrophil count in sputum		24hrs after LPS inhalation	No
Secondary	white blood cells and differential in peripheral blood		0, 6 and 24 hrs after LPS inhalation	No
Secondary	CC16 in peripheral blood		0, 6 and 24hrs after LPS inhalation	No
Secondary	Calgranulin A/B		0, 6 and 24hrs after LPS inhalation	No
Secondary	CRP in peripheral blood		0, 6 and 24hrs after LPS inhalation	No
Secondary	Spirometry (FEV1 and FEV1/FEV)		0, 1, 6 and 24hrs after LPS inhalation	Yes
Secondary	Alveolo-capillary diffusion		0, 6 and 24hrs after LPS inhalation	No
Secondary	12-lead ECG		Screening Visit 1 and final Visit 5	Yes
Secondary	Physical exam	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	Yes
Secondary	Safety labs from peripheral blood	hematology, blood chemistry (ionogram, AST, ALT, alkaline phosphatases, urea, creatinine)	At the Screening Visit 1 and the Final Visit 5	Yes