The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma

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.

Conditions

• Allergic Asthma Due to Dermatophagoides Pteronyssinus

Interventions

DRUG

ODACTRA 12 SQ-HDM Sublingual Tablet

Subjects are randomized to either HDM-AIT or Placebo for 24 weeks of therapy

DRUG

Placebo sublingual tablet

Subjects are randomized to either HDM-AIT or Placebo for 24 weeks of therapy

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• ALK-Abelló A/S

  collaborator INDUSTRY

• Lund University

  collaborator OTHER

• Bispebjerg Hospital

  lead OTHER

Principal Investigators

• Celeste Porsbjerg, Professor · Respiratory Research Unit, department of Respiratory Medicine, Bispebjerg University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-20

Primary Completion

2022-02-27

Completion

2022-02-27

FDA Drug

Yes

Countries

• Denmark

Study Locations