Immune Response Features in Allergic Airway Diseases

April 16, 2020 updated by: Brigita Sitkauskiene, Lithuanian University of Health Sciences

Investigation of Phenotypes, Endotypes and Immune Response Features in Allergic Airway Diseases

This study aims to investigate immune mechanisms and phenotypes and endotypes of allergic airway diseases - allergic rhinitis and allergic asthma. Pathogenesis of these diseases are not fully investigated yet. Patients with the same disease have different dominant symptoms, course of the disease and response to treatment. Moreover, there is a hypothesis about united airway disease suggesting that allergic rhinitis and allergic asthma is different manifestation of the same disease. This led to assumption of phenotypes and endotypes. This classification which still is not unified can let to prescribe personalized treatment for every patient.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with allergic rhinitis with or without asthma and healthy individuals for control group.

Description

Inclusion Criteria:

  • Hypersensitivity to house dust mites
  • Allergic rhinitis with or without mild to moderate asthma

Exclusion Criteria:

  • Acute or chronic infections
  • Use of systemic immunosupresants (wait 1 month)
  • Use of systemic or local antihistamines (wait 1 week)
  • Use of intranasal steroids (wait 1 month)
  • Oncological or active autoimmune diseases

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
Intervention / Treatment
Healthy individuals
Procedure: Nasal provocation test
Allergen extract under controlled conditions will be applied into nasal mucous.
Allergic rhinitis patients
Procedure: Nasal provocation test
Allergen extract under controlled conditions will be applied into nasal mucous.
Allergic rhinitis and asthma patients
Procedure: Nasal provocation test
Allergen extract under controlled conditions will be applied into nasal mucous.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
Time Frame: 2 hours

Cytokines (IL-13, IL-10, IL-22, etc.) level will be measured by ELISA before and after nasal provocation test with house dust mites.

Comparison between different groups.
2 hours
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
Time Frame: 22 hours
Cytokines (IL-13, IL-10, IL-22, etc.) level will be measured by ELISA before and after nasal provocation test with house dust mites.
22 hours

Collaborators and Investigators

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

Sponsor

Lithuanian University of Health Sciences

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)

May 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

April 1, 2024

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (ACTUAL)

April 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKTL1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Allergic Rhinitis

Clinical Trials on Nasal provocation test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe