Integrative Omics Approach to Allergic Rhinitis (IntegOmics)

March 13, 2024 updated by: Medical University of Graz

Crosstalk of Nasal Epithelium and Mucus in the Immune Response to Allergic Rhinitis: an Integrative Omics Approach to Measure Abundance Changes in Protein and RNA Expression

Nasal mucus and nasal epithelium are the first defense barriers against allergens. Various proteins are found in nasal mucus that play a role in allergic rhinitis and reflect immune response to allergen exposure. The difference in the proteomic profile of allergic rhinitis patients and healthy controls can give insight about how the response works and which proteins could lead to either enhanced immune reaction or to defense response like augmentation of epithelial integrity. It is also known that the airway epithelium plays a crucial role in the regulation of airway immune responses and inflammation. Gene expression profiling is widely used to analyses complex disease. For the airway epithelium gene expression profile in diseased and healthy state as well as in baseline and provoked state can clarify the mechanism of defense reactions and the course of inflammatory processes. Nasal mucus proteins as consequence of different gene expression can be seen as part of the end products of this complex mechanisms and interactions between allergens and the epithelium.

Nasal mucus proteins have different origins and production sites and gene expression does not necessarily result in functional metabolites. The aim of this proposed project is to try and analyze in a holistic proteomic approach the response to allergen on a genetic/genomic level from the nasal epithelium to protein/proteomic level in nasal mucus. This analysis gives us insight of how the different gene expression profiles result in a protein expression and further clarifies which proteins are directly originate from the epithelium and which are result of plasma exudation or underlie different regulatory processes.

From allergic rhinitis patients and healthy controls nasal mucus, nasal mucosa, and serum will be obtained. Nasal mucus will be collected with a special suction device equipped with a mucus trap from the middle meatus under endoscopic control without touching the mucosa. Nasal mucosa will be obtained through nasal brushes under local anesthesia and put into primary culture. Serum prepared from blood samples. Patients with grass or tree pollen allergy will be included and allergic state will be determined by skin prick tests and RAST (Radio-Allergo-Sorbent-test). The aimed for sample size will be 15 patients per group. Samples will be obtained in and out of pollen season. Allergic patients will fill out a symptom score and samples will be taken when symptoms are strong (in pollen season) and disappeared (out of pollen season). For healthy controls the time point of sample taking will be correlated to the allergic rhinitis patients to have a similar pollen exposure. Nasal mucus will be sent for Liquid Chromatography Tandem mass spectrometry for proteomic analysis and from nasal epithelial cells RNA will be isolated and send for Microarray analysis. By an integrative omics approach gene and protein expression will be correlated and cross talk between nasal mucus and epithelium will be analysed. The identification of key genes or gene clusters leads to further identification of key proteins or protein groups as biomarkers that could serve for novel therapeutic or diagnostic strategies in allergic rhinitis. The integrative omic approach downsizes the potential candidates since the focus lies on epithelial gene expression and their protein products and excludes proteins that are highly abundant without direct correlation to allergen exposure e.g. through plasma exudation. Moreover, the genomic and proteomic analysis could explain in more detail how the barrier of mucus and epithelium are affected by allergen exposure. The comparison to healthy controls and the longitudinal changes throughout the season further sheds light on how these individuals react upon allergen exposure and how this could lead to prevention of sensitization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • ENT University Hospital Graz

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Allergic Rhinitis Patients and Healthy conrols

Description

Inclusion Criteria:

  • pollen allergy verified by skin-prick test, blood tests for specific Immunoglobulin class E (RAST) and allergic rhinitis symptoms

Exclusion Criteria:

  • chronic infectious diseases
  • bad overall health condition
  • malignant disease,
  • pregnancy
  • long-term intake of nasal and/or systemic steroids
  • antihistamines or leukotrienes
  • allergen immunotherapy
  • acute and/or chronic rhinosinusitis
  • parallel participation in other studies

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy Controls
Allergic Rhinitis Patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abundance Change of proteins
Time Frame: 1 year
Abundance change of proteins will be measured semiquantitatively according to normalised mean areas under the curve of the respective experimental spectrum obtained from a distinct protein between the groups and seasons
1 year
Abundance Change of RNA/Genes
Time Frame: 1 year
RNA Expression and gene expression will be measured by microarrays and fold changes will be obtained between the groups and seasons
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IntegrativeOmics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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