- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05245175
Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions (SIMBA)
Assessment of Impact of Different Carrier Solutions for House Dust Mite Allergen (HDM) Challenge on Allergic Reactions in Patients With HDM Allergic Rhinitis
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Allergen Challenge Chambers (ACC) are used worldwide since many years to test anti-allergic treatment in early clinical development. ACCs provide the advantage of controlled atmospheres with stable allergen load and highly reproducible symptoms during challenges.
The Fraunhofer ACC has been used since more than 20 years to test a range of different anti-allergic treatments, mostly using pollen challenges.
For house dust mite (HDM) challenges, a carrier solution containing lactose or sodium chloride is reconstituted with commercially available HDM allergen. The solution is spray-dried to create allergen loaded lactose or sodium chloride particles of a determined size. Those particles are distributed in the ACC.
Whether lactose or sodium chloride particles alone could induce nasal irritation during allergen challenges, has not been examined. Should allergen-free carrier solutions contribute to nasal symptoms, study results might be confounded. Even more so, if one carrier solution caused more nasal irritation than the other.
To determine if allergen-free carrier solutions alone irritate the nasal mucosa, we expose subjects with allergic rhinitis and house dust mite allergy to three different atmospheres: (1) lactose particles alone, (2) sodium chloride particles alone, and (3) clean air. Also, we aim to document nasal symptoms during challenges with HDM-containing carrier solutions to decide on the best carrier option for future clinical trials.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Lower Saxony
-
Hannover, Lower Saxony, Allemagne, 30625
- Fraunhofer Institute for Toxicology and Experimental Medicine
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Able and willing to give written informed consent.
Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.
- Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first allergen challenge until at least 72 hours after the last allergen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Body mass index between 18 and 32 kg/m2
- History of HDM-induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening.
- Positive skin prick test responses (positive wheal diameter reaction of ≥ 3 mm larger than the negative control and wheal diameter < 2 mm to the sodium chloride/diluent negative control) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
- Serum specific IgE level (≥ 0.7 kU/L) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
- FEV1 of 80% of predicted value or greater at screening. If subject fails to achieve this value, the assessment may be repeated 2 additional times.
- Total Nasal Symptom Score (TNSS) of ≤ 3 prior to entering the chamber at visit 2.
- Smokers or non-smokers.
Exclusion Criteria:
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or ECG at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- Diastolic blood pressure above 95 mmHg.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- History of an acute infection at screening that has not resolved four weeks prior to visit 2.
- Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps).
- Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active (i.e., grass, trees, weeds, rye; defined as IgE ≥ 3.5 kU/L [IgE samples drawn within 12 months prior to screening can be used to assess criteria as long as they are performed and documented at the clinical unit]; OR symptomatic to aeroallergens within the past 2 years or within the past 2 allergy seasons; OR both) through the completion of the study.
- Concomitant allergy to an animal dander who has exposure on a regular basis to the respective animal dander.
- History of allergic reactions such as anaphylactic shock, exanthema generalized, angioedema or hypotension caused by HDM and/or any medical products (including vaccine) in the past.
- Known or suspected clinically relevant intolerance to lactose .
- Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines.
- Participation in another clinical trial 30 days prior to enrollment.
- Donation of more than 400 ml of blood the preceding 2 months before screening.
- History of regular drug or alcohol abuse in the past 3 months.
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Specific Immunotherapy (SIT) within five years prior to the study.
- Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
- Systemic immunosuppression treatment (e.g. oral steroids, biologics, e.g. dupilumab, JAK-Inhibitors, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF) within 3 months before visit 2
- Treatment with anti-allergic medication or topical steroids (within 2 weeks before visit 2)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Sodium chloride particles
Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Expérimental: Lactose particles
Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Comparateur placebo: Clean air
Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Expérimental: Sodium chloride particles with house dust mite
Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Expérimental: Lactose particles with house dust mite
Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air.
Délai: Day 1, Day 2, Day 3
|
TNSS = Total Nasal Symptom Score (min = 0 = no symptoms; max = 12 = max symptoms)
|
Day 1, Day 2, Day 3
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of mean VAS of symptoms during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air
Délai: Day 1, Day 2, Day 3
|
VAS = Visual Analogue Scale (min = 0 = no symptoms; max = 10 = max symptoms)
|
Day 1, Day 2, Day 3
|
Difference in nasal secretion weight during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air
Délai: Day 1, Day 2, Day 3
|
Pre-weighed handkerchief sachets used by subjects during challenge are weighed after use to determine nasal secretion amount
|
Day 1, Day 2, Day 3
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either HDM allergen with lactose particles compared to challenges with HDM allergen with sodium chloride particles.
Délai: Day 4, Day 11
|
TNSS = Total Nasal Symptom Score
|
Day 4, Day 11
|
Change of nasal secretion weight during challenge over 4 hours with either HDM allergen with lactose particles compared to challenges with HDM allergen with sodium chloride particles
Délai: Day 4, Day 11
|
Pre-weighed handkerchief sachets used by subjects during challenge are weighed after use to determine nasal secretion amount
|
Day 4, Day 11
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Jens M Hohlfeld, Prof. Dr., Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
Autres numéros d'identification d'étude
- 22-05 SIMBA
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .
Essais cliniques sur Sodium chloride particles
-
Institut d'Anesthesiologie des Alpes MaritimesUniversité de Nice Sophia Antipolis; Medical University of GrenobleComplété
-
University of DelawareComplétéPression artérielle | Réactivité cérébrovasculaireÉtats-Unis
-
University of DelawareComplété
-
Radboud University Medical CenterInconnueDiabète de type 1 | Ignorance de l'hypoglycémiePays-Bas
-
Austin HealthComplétéSyndrome de réponse inflammatoire systémique | Insuffisance rénale | OligurieAustralie
-
Medical University of GrazComplétéCrise cardiaqueL'Autriche
-
Osaka General Medical CenterComplétéProcédure coronarienne urgenteJapon
-
Lars Wiuff AndersenUniversity of AarhusRecrutement
-
Radboud University Medical CenterEuropean Foundation for the Study of Diabetes; Dutch Diabetes Research FoundationComplétéDiabète sucré de type 1 avec hypoglycémiePays-Bas