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Completed

NCT Number: NCT01985542

The Effects of Immunotherapy in the Nose

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • allergic rhinoconjunctivitis of birch pollen OR healthy controls

Exclusion criteria

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

Treatment and study plan

birch pollen subcutaneous immunotherapy

Drug

birch pollen subcutaneous immunotherapy

Primary outcomes

  1. The Total Number of Differentially Expressed Transcripts.

    Time frame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.

    Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups.

    The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.

Secondary outcomes

  1. Percentage Change in Visual Analogue Scale Scores of Symptoms

    Time frame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.

    Visual analogue scale (VAS) was measured as 0-100 mm per each symptom question. VAS value 0 (mm) indicates no symptoms, and value 100 (mm) indicates the worst case.

    Total VAS score = sum of the VAS scores for the 41 symptoms The minimum value of the total VAS score is 0, and the maximum value is 4100. Relative change = [(measure at time +6 months - measure at time -6 months)]/measure at time -6 months * 100%.

    Measure = total VAS score

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Institute of Occupational Health
  • University of Helsinki

Registry information

Official study title

The Molecular Biological Effects of Immunotherapy in the Nose

Acronym: Birch11

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2013
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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