The Effects of Immunotherapy in the Nose (Birch11)

May 30, 2021 updated by: Sanna Salmi, Helsinki University Central Hospital

The Molecular Biological 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • allergic rhinoconjunctivitis of birch pollen OR healthy controls

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: subcutaneous immunotherapy
Starts with birch pollen subcutaneous immunotherapy
Drug: birch pollen subcutaneous immunotherapy
birch pollen subcutaneous immunotherapy
NO_INTERVENTION: no immunotherapy
not starting with birch pollen subcutaneous immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
-6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
-6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki
Finnish Institute of Occupational Health

Investigators

  • Principal Investigator: Sanna K Salmi, MD PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The effects of immunotherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data is not shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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