- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02301884
Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis (pILIT)
Open-labeled Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
After informed consent, causal allergen was injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. Initial dose of allergen was 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and 1:1/10 weight/volume for dog hair/dander, HollisterStier, New Orleans, USA) in volume of 0.1ml. After the first dose, allergen concentration was escalated 3-fold at second dose, and 10-fold at third dose if there was no or mild local or systemic hypersensitivity reaction. The allergen concentration did not change at second or third dose if there was moderate local or systemic reaction. The allergen concentration was decreased by 10 or 100-fold from previous concentration if there was severe local or systemic reaction.
The investigators evaluated parameters regarding allergic rhinitis within a week before the first injection and 4 months after the first injection. These parameters included Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20), and Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life. Skin prick test, intradermal test, blood sampling for serum allergen-specific IgE, exhaled nitric oxide, and nasal lavage for Th1, Th2, and Treg cytokines were also included. Adverse events were recorded and graded according to Muller's classification and Ring and Messmer's classification.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Incheon, Korea, Republik von, 405-760
- Gachon University Gil Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Allergic rhinitis to house dust mite (Df, Dp), cat or dog
- More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST)
Exclusion Criteria:
- Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline
- FEV1 less than 50% of predicted value if there is comorbid asthma
- Subject rejects the enrollment into study
- Low compliance
- Pregnancy or lactation
- Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
- Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks
- Prior history of allergen-specific immunotherapy
- Allergic rhinitis caused by other perennial or seasonal allergen
- Vulnerable volunteer
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Allergen extract
Causal allergen such as D. farinae (30 AU/ml), D. pteronyssinus (30 AU/ml), cat hair (10 AU/ml), dog hair/dander (1:1/10 w/v), or combination of those. Allergen extract, HollisterStier, New Orleans, USA. Intralymphatic injection in volume of 0.1 ml, three times with 4-week interval. Concentration was increased, decreased, or unchanged at 2nd or 3rd injection according to local or systemic reaction after previous injection |
Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
RQLQ
Zeitfenster: Baseline and 4 months after the first injection
|
Rhinoconjunctivitis Quality of Life Questionnaire
|
Baseline and 4 months after the first injection
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
SNOT-20
Zeitfenster: Baseline and 4 months after the first injection
|
Sino-Nasal Outcome Test-20
|
Baseline and 4 months after the first injection
|
Skin reactivity
Zeitfenster: Baseline and 4 months after the first injection
|
Allergen/histamine ratio of mean wheal diameter in skin prick test, and allergen/saline ratio of mean wheal diameter in intradermal test
|
Baseline and 4 months after the first injection
|
Serum total and allergen-specific IgE and IgG4 level
Zeitfenster: Baseline and 4 months after the first injection
|
Serum total and allergen-specific IgE and IgG4 level using UNICAP, Thermofisher Scientific, Sweden
|
Baseline and 4 months after the first injection
|
Nasal reactivity
Zeitfenster: Baseline and 4 months after the first injection
|
Symptom score and volume 2-6 cm in acoustic rhinometry during nasal provocation test with D. farinae and/or D. pteronyssinus in allergic rhinitis patients sensitized to house dust mite
|
Baseline and 4 months after the first injection
|
Cytokines in nasal lavage fluid
Zeitfenster: Baseline and 4 months after the first injection
|
Cytokines of Th1, Th2, and Treg in nasal lavage fluid
|
Baseline and 4 months after the first injection
|
Exhaled NO
Zeitfenster: Baseline and 4 months after the first injection
|
Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
|
Baseline and 4 months after the first injection
|
Respiratory and dermatologic symptoms provoked by allergen exposure in daily life
Zeitfenster: Baseline and 4 months after the first injection
|
Visual analogue scale of respiratory and dermatologic symptoms provoked by allergen exposure in daily life (ranged from 0 to 100)
|
Baseline and 4 months after the first injection
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Sang Min Lee, M.D., Ph.D., Gachon University Gil Medical Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.
- Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.
- Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available.
- Zaleska A, Eiwegger T, Soyer O, van de Veen W, Rhyner C, Soyka MB, Bekpen C, Demiroz D, Treis A, Sollner S, Palomares O, Kwok WW, Rose H, Senti G, Kundig TM, Ozoren N, Jutel M, Akdis CA, Crameri R, Akdis M. Immune regulation by intralymphatic immunotherapy with modular allergen translocation MAT vaccine. Allergy. 2014 Sep;69(9):1162-70. doi: 10.1111/all.12461. Epub 2014 Jul 12. Erratum In: Allergy. 2016 Jan;71(1):129.
- Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.
- Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7.
- Kundig TM, Johansen P, Bachmann MF, Cardell LO, Senti G. Intralymphatic immunotherapy: time interval between injections is essential. J Allergy Clin Immunol. 2014 Mar;133(3):930-1. doi: 10.1016/j.jaci.2013.11.036. Epub 2014 Jan 15. No abstract available.
- Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy: from the rationale to human applications. Curr Top Microbiol Immunol. 2011;352:71-84. doi: 10.1007/82_2011_133.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GBIRB2013-35
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Allergischer Schnupfen
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRekrutierungGanzjährige allergische Rhinitis | Saisonale allergische Rhinitis | Lokale allergische RhinitisBelgien
-
Organon and CoAbgeschlossenGanzjährige allergische Rhinitis | Saisonale allergische Rhinitis
-
BayerAbgeschlossenSaisonale allergische Rhinitis | Vasomotorische Rhinitis
-
ALK-Abelló A/SAbgeschlossenGanzjährige allergische Rhinitis | Saisonale allergische Rhinitis
-
Humanis Saglık Anonim SirketiAbgeschlossenGanzjährige allergische Rhinitis | Saisonale allergische RhinitisIndien
-
Organon and CoAbgeschlossenGanzjährige allergische Rhinitis | Saisonale allergische Rhinitis
-
Organon and CoAbgeschlossenGanzjährige allergische Rhinitis | Saisonale allergische Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationAbgeschlossenAllergie | Ganzjährige allergische Rhinitis | Saisonale allergische RhinitisVereinigte Staaten
-
GlaxoSmithKlineAbgeschlossenRhinitis, allergisch, mehrjährig und saisonalVereinigte Staaten
-
GlaxoSmithKlineAbgeschlossenRhinitis, Allergiker, StaudeVereinigte Staaten
Klinische Studien zur Allergen extract
-
TCI Co., Ltd.Abgeschlossen
-
BiomixKyunghee UniversityAbgeschlossenAufmerksamkeits-Defizit-Hyperaktivitäts-StörungKorea, Republik von
-
Pusan National University Yangsan HospitalRekrutierungLeberkrankheitenKorea, Republik von
-
The Hospital for Sick ChildrenUnbekanntMekoniumaspirationssyndromKanada