The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma
Status:
Active, not recruiting
Trial end date:
2022-07-30
Target enrollment:
Participant gender:
Summary
Aim: To investigate the possible immune modulatory effects of allergen immunotherapy (AIT) on
respiratory immunity in patients with allergic asthma (AA).
Background: Allergic sensitization to aeroallergens is a common co-morbidity in asthma that
is associated with more frequent and severe asthma attacks. The investigators have recently
shown that patients with allergic asthma also have an increased risk of pneumonia, and hence
allergy in asthma may be associated with a relative respiratory immunodeficiency. However,
the increased risk was obliterated in patients treated with AIT.
Methods: Patients with asthma sensitized to house-dust mite (HDM) is enrolled in a
randomized, double-blind, placebo-controlled study of HDM-AIT. Patients will be scheduled for
9 visits through 8 months including, randomization to 6 months of treatment with either
HDM-AIT (Acarizax/Odactra) or placebo. Primary interferons (IFN) type I and III will be
investigated in human bronchial epithelial cells as the primary outcome. Secondary outcomes
such as: Inflammatory cytokines, immunologic phenotype and immunohistochemistry will be
investigated in bronchial biopsies, blood, bronchoalveolar lavage fluid, sputum and HDM-patch
biopsies as well as a thorough respiratory and allergic evaluation.
Expected outcomes: The investigators expect that, patients with AA have 1) decreased
production of anti-viral type I and III IFN and that AIT increases these measures. 2)
Anti-bacterial response is reduced through IL12, ß-defensin and IFN-γ and that AIT increases
these measures. 3) Lastly, the investigators expect that T-cell response is dysregulated
(Th1↓1/Th2↑) in patients with AA and that these findings are modulated in an
immuno-protective direction after AIT.
Perspectives: This project will expand our understanding of the clinical significance of
allergy in asthma in a completely novel direction and show how AIT may modulate the immune
response to prevent infections.
Phase:
Phase 4
Details
Lead Sponsor:
Bispebjerg Hospital
Collaborators:
ALK-Abelló A/S Allergy- and pulmonary Clinic, Vanloese. Lund University University of Copenhagen