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Nasal Mucus Proteome and Immunotherapy

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ClinicalTrials.gov Identifier: NCT02159404
Recruitment Status : Recruiting
First Posted : June 9, 2014
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Tomazic Peter Valentin, MD, Medical University of Graz

Study Description
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Brief Summary:

Nasal mucus as first line defense barrier of the nasal mucosa contains a variety of proteins that act as functional units. We recently showed that the nasal mucus proteome between allergic rhinitis patients and healthy controls is significantly altered.

The aim of the present project is to show changes in nasal mucus proteome between allergic rhinitis patients and healthy controls over the pollen and non pollen season and to further determine whether and if so how the proteome changes under immunotherapy. Patients and healthy controls will be enrolled at two time points namely during the pollen season and out of the pollen season. Statistical differences will be determined within the groups and between the groups as well as impact of immunotherapy on patients undergoing therapy.

Mucus will be collected with a special suction device equipped with a mucus trap. Then, proteomic analysis will be performed by LC MS/MS mass spectrometry. Database search will identify distinct proteins and their function, origin etc. will be annotated. Protein groups will be analyzed through pathway enrichment and cluster analysis. Furthermore, mechanisms of immunotherapy in responders and success or failure of therapy could be determined. These could lead to the identification of potential biomarkers.


Condition or disease Intervention/treatment
Allergic Rhinoconjunctivitis Biological: Immunotherapy

Detailed Description:

Nasal mucus as first line defense barrier of the nasal mucosa contains a variety of proteins that act as functional units. We recently showed that the nasal mucus proteome between allergic rhinitis patients and healthy controls is significantly altered. On protein level, immune response in allergic rhinitis is enhanced and barrier function is reduced as reflected by increased epithelial permeability. Moreover, there is an unfavorable imbalance in innate anti-proteases. Proteases in pollen grain could therefore not be adequately deactivated in the mucus further damaging the epithelium which leads to submucosal penetration of allergens and facilitated presentation to antigen presenting cells.

The aim of the present project is to show changes in nasal mucus proteome between allergic rhinitis patients and healthy controls over the pollen and non pollen season and to further determine whether and if so how the proteome changes under immunotherapy. For the first aim patients and healthy controls will be enrolled at two time points namely during the pollen season and out of the pollen season. Statistical differences will be determined within the groups and between the groups. The protein changes over the time course reflect how allergics but also healthy controls react to allergen challenge. The results should give insight on possible biomarkers that could be used for diagnostics and therapy. Protein substitution or inhibition may be a future therapy to reinforce the barrier function of nasal mucus and treat allergic rhinitis symptoms. The effect of immunotherapy as sole causal therapy will be determined and therapy responders will be compared to non-responders. We hypothesize that responders will show proteome changes similar to healthy conditions. This further concretizes distinct proteins as biomarkers that could be used as therapeutic agents. Moreover proteome changes could be used to predict and monitor therapeutic success or failure and patients may be stratified to be subjected to other therapeutic strategies than immunotherapy saving time and money.

Mucus will be collected with a special suction device equipped with a mucus trap. Then, proteomic analysis will be performed by LC MS/MS mass spectrometry. Database search will identify distinct proteins and their function, origin etc. will be annotated. Protein groups will be analyzed through pathway enrichment and cluster analysis. By this means complex proteomic data can be visualized for a better understanding of global changes in protein networks and functions.

Investigating the nasal mucus proteome in diseased and healthy state leads to a better understanding of its barrier function and reaction to allergens. Distinct proteins and/or proteins groups could be used as biomarkers for novel diagnostic and therapeutic approaches. Furthermore, mechanisms of immunotherapy in responders and success or failure of therapy could be determined.

Study Design
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Study Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Seasonal Differences in Nasal Mucus Proteome and Impact of Immunotherapy
Study Start Date : April 2015
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 1, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Allergic Rhinoconjunctivitis
Patients with diagnosed Allergic Rhinoconjunctivitis
 Biological: Immunotherapy
Healthy controls


Outcome Measures
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Primary Outcome Measures :
  1. AUC of protein spectra obtained by mass spectrometry [ Time Frame: 3 years ]
    Areas under the curve of protein spectra will be determined


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Allergic Rhinoconjunctivitis Healthy controls
Criteria

Inclusion Criteria:

  • pollen allergy verified by skin-prick test, blood tests for specific IgE (RAST) and allergic rhinitis symptoms, eligible for immunotherapy

Exclusion Criteria:

  • chronic infectious diseases, bad overall health condition, pregnancy, long-term intake of nasal and/or systemic steroids or antihistamines, acute and/or chronic rhinosinusitis and parallel participation in other studies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159404


Contacts
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Contact: Peter V Tomazic, M.D. +4331638581347 ext +4331638583448 peter.tomazic@medunigraz.at

Locations
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Austria
ENT University Hospital Graz Recruiting
Graz, Styria, Austria, 8036
Sub-Investigator: Ruth Birner-Grünberger, PhD         
Sub-Investigator: Doris Lang-Loidolt, M.D.         
Sponsors and Collaborators
Medical University of Graz
More Information
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Publications:

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Responsible Party: Tomazic Peter Valentin, MD, Medical Doctor, Medical University of Graz
ClinicalTrials.gov Identifier: NCT02159404    
Other Study ID Numbers: ProtOmicsSeasons01
KLI 425-B23 ( Other Grant/Funding Number: Austrian Science Fund (FWF) )
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023