Clinical trial NCT01985542: The Effects of Immunotherapy in the Nose
Official title: The Molecular Biological Effects of Immunotherapy in the Nose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Finnish Institute of Occupational Health
First posted: 2013-11-15
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* allergic rhinoconjunctivitis of birch pollen OR healthy controls

Exclusion Criteria:

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

Primary outcomes:
measure: The Total Number of Differentially Expressed Transcripts.
timeFrame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Secondary outcomes:
measure: Percentage Change in Visual Analogue Scale Scores of Symptoms
timeFrame: -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Sanna K Salmi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mattila P, Renkonen J, Toppila-Salmi S, Parviainen V, Joenvaara S, Alff-Tuomala S, Nicorici D, Renkonen R. Time-series nasal epithelial transcriptomics during natural pollen exposure in healthy subjects and allergic patients. Allergy. 2010 Feb;65(2):175-83. doi: 10.1111/j.1398-9995.2009.02181.x. Epub 2009 Oct 5.
citation: Joenvaara S, Mattila P, Renkonen J, Makitie A, Toppila-Salmi S, Lehtonen M, Salmi P, Lehti S, Makinen J, Sormunen R, Paavonen T, Renkonen R. Caveolar transport through nasal epithelium of birch pollen allergen Bet v 1 in allergic patients. J Allergy Clin Immunol. 2009 Jul;124(1):135-142.e1-21. doi: 10.1016/j.jaci.2008.11.048. Epub 2009 Apr 2.