- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01714427
Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment
The purpose of this study is to investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model.
The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Vienna, L'Autriche, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
- Nonsmoker
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- If female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method)
- Negative urine pregnancy test
Exclusion Criteria:
- Known or suspected allergy to trial product or related products
- Pregnancy or Lactation
- Treatment with an investigational drug within three weeks prior to this trial
- Participation in an LPS trial within the last 6 weeks
- Smoking
- History of relevant cardiac arrhythmia
- Preexisting open or closed angle glaucoma
- History of Osteoporosis, Cushing´s syndrome, gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of neurosurgery
- Systemic tuberculosis
- Hemorrhagic diathesis
- Relevant liver or kidney dysfunction
- Regular use of medication or abuse of alcohol unless considered clinically relevant
- Use of any medication within one week prior to the first trial day
- Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
- Excessive sporting activities
- Rosacea
- Subjects on Monoamine oxidase inhibitors (should be stopped for at least two to three weeks before dihydrocodeine treatment is initiate)
- Known acute or active hepatic disease within the past 3 months
- A platelet count < 100,000 x 106/L, prothrombin time > 1.5, liver enzymes> 3 times the upper normal limit
- Having received a vaccination up to 8 weeks before the trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Dexaméthasone
|
Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.
|
|
Comparateur placebo: Sterile isotonic saline
|
two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified.
Délai: 6/24 hours after LPS Instillation
|
6/24 hours after LPS Instillation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bernd Jilma, MD, Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Inflammation
- Pneumonie
- Effets physiologiques des médicaments
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Dexaméthasone
Autres numéros d'identification d'étude
- DEXA - LIM
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .