Immune Response Features in Allergic Airway Diseases

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352088
• Other study ID #: AKTL1
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: April 2024

Study information

• Verified date: April 2020
• Source: Lithuanian University of Health Sciences
• Contact: Laura Tamasauskiene, MD
• Phone: +37061569127
• Email: lau.tamasauskiene[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Procedure:
• Nasal provocation test
Allergen extract under controlled conditions will be applied into nasal mucous.

Locations

Country	Name	City	State
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.	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
Primary	Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.	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