Allergic Rhinitis Clinical Trial
Official title:
Documentation of Efficacy for Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group, Double Blind Placebo-controlled Multisite Field Trial
Verified date | May 2024 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal is to investigate the efficacy of intralymphatic immunotherapy (ILIT) for the treatment of allergic rhinitis and allergic asthma due to sensitisation to grass pollen allergens. 60 patients with allergic rhinitis will be included and randomized to receive either Polvac (n=30) or placebo (n=30). All patients will receive three injections with 4-8 weeks interval. The injections into a inguinal lymph node is guided by sonography. Patients will record symptoms and medication use in the summer of 2022 and 2023.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - passed online screening with a Rhinoconjunctivitis Total Symptom Score (RTSS) value of 8 or higher. - sensitisation to grass pollen allergens with a skin prick test reaction to grass pollen allergen of 3 mm or more. - eligible to allergen immunotherapy. - 18 years or older. - comfortable with digital data entry. Exclusion Criteria: - previous grass pollen-specific immunotherapy. - significant allergy to mugwort or pet animal allergens. - uncontrolled asthma. - upper airway disease. - severe pulmonary disease. - recent allergic reactions. - immunosuppression. - cardiovascular disease. - malignant disease. - use of ACE-blockers. - other diseases or conditions rendering the treatment of anaphylactic reactions difficult. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | University of Aarhus |
Switzerland,
Aini NR, Mohd Noor N, Md Daud MK, Wise SK, Abdullah B. Efficacy and safety of intralymphatic immunotherapy in allergic rhinitis: A systematic review and meta-analysis. Clin Transl Allergy. 2021 Aug 17;11(6):e12055. doi: 10.1002/clt2.12055. eCollection 202 — View Citation
Freiberger SN, Zehnder M, Gafvelin G, Gronlund H, Kundig TM, Johansen P. IgG4 but no IgG1 antibody production after intralymphatic immunotherapy with recombinant MAT-Feld1 in human. Allergy. 2016 Sep;71(9):1366-70. doi: 10.1111/all.12946. Epub 2016 Jun 17 — View Citation
Hoang MP, Seresirikachorn K, Chitsuthipakorn W, Snidvongs K. Intralymphatic immunotherapy for allergic rhinoconjunctivitis: a systematic review and meta-analysis. Rhinology. 2021 Jun 1;59(3):236-244. doi: 10.4193/Rhin20.572. — View Citation
Schmid JM, Nezam H, Madsen HH, Schmitz A, Hoffmann HJ. Intralymphatic immunotherapy induces allergen specific plasmablasts and increases tolerance to skin prick testing in a pilot study. Clin Transl Allergy. 2016 May 25;6:19. doi: 10.1186/s13601-016-0107- — View Citation
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 onl — View Citation
Senti G, Freiburghaus AU, Larenas-Linnemann D, Hoffmann HJ, Patterson AM, Klimek L, Di Bona D, Pfaar O, Ahlbeck L, Akdis M, Weinfeld D, Contreras-Verduzco FA, Pedroza-Melendez A, Skaarup SH, Lee SM, Cardell LO, Schmid JM, Westin U, Dollner R, Kundig TM. I — View Citation
Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7. — View Citation
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. — View Citation
Skaarup SH, Graumann O, Schmid J, Bjerrum AS, Skjold T, Hoffmann HJ. The number of successful injections associates with improved clinical effect in intralymphatic immunotherapy. Allergy. 2021 Jun;76(6):1859-1861. doi: 10.1111/all.14642. Epub 2020 Nov 16. — View Citation
Skaarup SH, Schmid JM, Skjold T, Graumann O, Hoffmann HJ. Intralymphatic immunotherapy improves grass pollen allergic rhinoconjunctivitis: A 3-year randomized placebo-controlled trial. J Allergy Clin Immunol. 2021 Mar;147(3):1011-1019. doi: 10.1016/j.jaci — View Citation
Werner MT, Bosso JV. Intralymphatic immunotherapy for allergic rhinitis: A systematic review and meta-analysis. Allergy Asthma Proc. 2021 Jul 1;42(4):283-292. doi: 10.2500/aap.2021.42.210028. — View Citation
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 immunotherap — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined symptom medication score (cSMS) | Daily registration of symptoms and medication usage by the study participants and by means of a online application. This is done during the pollen season of 2022 (and possible 2023 if the 2022 season is poor with low amounts of pollen). The assessment is done over a time period, but the records are integrated for the calculation of one single score (cSMS), which is the primary outcome. | 3 months (2 minutes per day) | |
Secondary | Rhino conjunctivitis quality of life score (RQLQ) | Weekly questionnaire for studying the quality of life of the study participants during the pollen season of 2022 (and possible 2023 if the 2022 season is poor with low amounts of pollen). The RQLQ will assess seven domains on a weekly basis on a scale from 0 (best) to 6 (worst). The assessment is done over a long time period, but the records are integrated for the calculation of one single score (RQLC), which is the secondary outcome. | 3 months (10 minutes per week) | |
Secondary | Lower airway disease | We will assess spirometry, at each follow-up time point (winter and summer visits) and analyse a time series of the development of each parameter in each treatment group. The assessments will be performed at several time-points and the changes from baseline assessments (before ILIT) is measured. | 10 minutes (5 times in two years) | |
Secondary | Asthma | We will assess FeNo (Fraction Exspiratory Nitric Oxide) at each follow-up time point (winter and summer visits) and analyse a time series of the development of each parameter in each treatment group. The assessments will be performed at several time-points and the changes from baseline assessments (before ILIT) are measured. | 10 minutes (5 times in two years) | |
Secondary | Biomarkers | Circulating levels of IgE, IgG1, and IgG4 specific for grass pollen extract and the major allergens Phl p 5 and Phl p 1 will be determined in blood samples before every treatment and at all the follow-up visits, for a total of 7 times per participant. The analysis is done using ImmunoCAP ELISA. In addition, IgE assessment by ISAC (112 allergens in one array) will be performed to analyse if sensitisation to other allergens develops or changes. All assessments will be performed at several time-points and the changes from baseline assessments (before ILIT) are measured. | 5 minutes (8 times in two years) |
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