The Effects of Immunotherapy in the Nose (Birch11)

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: birch pollen subcutaneous immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01985542

The effects of immunotherapy

Details and patient eligibility

About

Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.

Full description

This is a controlled study with an intervention arm, and a control group of healthy volunteers. The population is composed of nonsmoking healthy adults and patients having birch or timothy pollen allergy with rhinoconjuctivitis symptoms and without other diseases. The diagnosis of pollen allergy is verified with positive history, skin prick test, and allergen specific IgE antibodies. Subjects undergo a spirometry with a bronchodilatator test and a histamine challenge. Quality of life and patient history data is collected by questionnaires. Four peripheral blood samples, as well as nasal cell swabs from nasal mucosa without local anesthesia are collected from each patient; in spring and winter before the group of the intervention arm starts with birch pollen subcutaneous immunotherapy; and during the first spring and winter when a subgroups has received the birch pollen immunotherapy. We plan to perform the following analyses for the nasal specimens: transcriptomics and their regulators, sequencing of 16SrRNA and RT-qPCR for assessing mucosal microbiome, mass spectrometry for analyses of proteins and protein-protein complexes, immunohistochemistry for tissue level localization and quantitation of proteins, in silico analyses for the data mining, integration and display. In addition we observe the alterations in inflammatory mediators after in vitro allergen activation of purified peripheral blood leukocytes by ELISA and real time qPCR.

Enrollment: 16 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• allergic rhinoconjunctivitis of birch pollen OR healthy controls

Exclusion criteria

• smoking, asthma, any other disease than allergic rhinoconjunctivitis, requiring constant medication

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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16 participants in 2 patient groups

subcutaneous immunotherapy

Active Comparator group

Description:

Starts with birch pollen subcutaneous immunotherapy

Treatment:

Drug: birch pollen subcutaneous immunotherapy

no immunotherapy

No Intervention group

Description:

not starting with birch pollen subcutaneous immunotherapy