Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-30 @ 3:11 AM
Study NCT ID:
NCT01081392
Status:
UNKNOWN
Last Update Posted:
2010-03-05
First Post:
2010-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Markers in Sputum After LPS Inhalation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-04', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute neutrophil count in sputum', 'timeFrame': '24hrs after LPS inhalation'}], 'secondaryOutcomes': [{'measure': 'white blood cells and differential in peripheral blood', 'timeFrame': '0, 6 and 24 hrs after LPS inhalation'}, {'measure': 'CC16 in peripheral blood', 'timeFrame': '0, 6 and 24hrs after LPS inhalation'}, {'measure': 'Calgranulin A/B', 'timeFrame': '0, 6 and 24hrs after LPS inhalation'}, {'measure': 'CRP in peripheral blood', 'timeFrame': '0, 6 and 24hrs after LPS inhalation'}, {'measure': 'Spirometry (FEV1 and FEV1/FEV)', 'timeFrame': '0, 1, 6 and 24hrs after LPS inhalation'}, {'measure': 'Alveolo-capillary diffusion', 'timeFrame': '0, 6 and 24hrs after LPS inhalation'}, {'measure': '12-lead ECG', 'timeFrame': 'Screening Visit 1 and final Visit 5'}, {'measure': 'Physical exam', 'timeFrame': 'At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit', 'description': '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'}, {'measure': 'Safety labs from peripheral blood', 'timeFrame': 'At the Screening Visit 1 and the Final Visit 5', 'description': 'hematology, blood chemistry (ionogram, AST, ALT, alkaline phosphatases, urea, creatinine)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LPS', 'endotoxin', 'inflammatory markers', 'healthy volunteers', 'neutrophils in sputum'], 'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '27331367', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteer, non-smoking or ex-smoker \\>1mth and \\<10packs/year\n* normal ECG\n* normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP\n* FEV1/forced vital capacity \\>0.7 and FEV1\\>80% of predicted value\n* able to produce valid sputum following induction (\\>=50% viable cells, \\<50% squamous cells and \\<60% neutrophils)\n* females must be using contraception\n* written informed consent\n\nExclusion Criteria:\n\n* infection within 14 days\n* history of bronchial asthma\n* obstructive respiratory condition with FEV1 \\<70% of theoretical value'}, 'identificationModule': {'nctId': 'NCT01081392', 'briefTitle': 'Inflammatory Markers in Sputum After LPS Inhalation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Brugmann'}, 'officialTitle': 'The Role of Inhaled Particle Size on the Inflammatory Response Induced by Endotoxin Inhalation', 'orgStudyIdInfo': {'id': 'CIA-01.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LPS sequence 1', 'description': 'Nebulizers A then B then C', 'interventionNames': ['Biological: LPS']}, {'type': 'EXPERIMENTAL', 'label': 'LPS sequence 2', 'description': 'Nebulizers B then C then A', 'interventionNames': ['Biological: LPS']}, {'type': 'EXPERIMENTAL', 'label': 'LPS sequence 3', 'description': 'Nebulizers C then A then B', 'interventionNames': ['Biological: LPS']}, {'type': 'EXPERIMENTAL', 'label': 'LPS sequence 4', 'description': 'Nebulizers A then C then B', 'interventionNames': ['Biological: LPS']}, {'type': 'EXPERIMENTAL', 'label': 'LPS sequence 5', 'description': 'Nebulizers C then B then A', 'interventionNames': ['Biological: LPS']}, {'type': 'EXPERIMENTAL', 'label': 'LPS sequence 6', 'description': 'Nebulizers B then A then C', 'interventionNames': ['Biological: LPS']}], 'interventions': [{'name': 'LPS', 'type': 'BIOLOGICAL', 'description': 'LPS 20mcg sd inhaled via nebulizer, 3 periods', 'armGroupLabels': ['LPS sequence 1', 'LPS sequence 2', 'LPS sequence 3', 'LPS sequence 4', 'LPS sequence 5', 'LPS sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Olivier MICHEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Brugmann', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Pierre Tassignon, MD, PhD, Head Clinical Research Unit', 'oldOrganization': 'CHU Brugmann'}}}}