Nasal Mucus Proteome and Immunotherapy

NCT02159404 | Recruiting

• 2 other identifiers: ProtOmicsSeasons01KLI 425-B23
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• AUC of protein spectra obtained by mass spectrometry

  Areas under the curve of protein spectra will be determined

  3 years

Study Arms (2)

Allergic Rhinoconjunctivitis

Patients with diagnosed Allergic Rhinoconjunctivitis

Biological: Immunotherapy

Healthy controls

Interventions

Immunotherapy BIOLOGICAL

Allergic Rhinoconjunctivitis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Allergic Rhinoconjunctivitis Healthy controls

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

ENT University Hospital Graz

Graz, Styria, 8036, Austria

RECRUITING

Related Publications (1)

• Tomazic PV, Birner-Gruenberger R, Leitner A, Obrist B, Spoerk S, Lang-Loidolt D. Nasal mucus proteomic changes reflect altered immune responses and epithelial permeability in patients with allergic rhinitis. J Allergy Clin Immunol. 2014 Mar;133(3):741-50. doi: 10.1016/j.jaci.2013.09.040. Epub 2013 Nov 28.

  PMID: 24290289 BACKGROUND

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Peter V Tomazic, M.D.

CONTACT

+4331638581347; peter.tomazic@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 9, 2014
• Study Start: April 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

AU (1)