Immune Response Features in Allergic Airway Diseases
Investigation of Phenotypes, Endotypes and Immune Response Features in Allergic Airway Diseases
1 other identifier
observational
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedApril 17, 2020
April 1, 2020
3.5 years
April 15, 2020
April 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Allergic rhinitis patients
Allergic rhinitis and asthma patients
Healthy individuals
Interventions
Allergen extract under controlled conditions will be applied into nasal mucous.
Eligibility Criteria
Adult patients with allergic rhinitis with or without asthma and healthy individuals for control group.
You may qualify if:
- Hypersensitivity to house dust mites
- Allergic rhinitis with or without mild to moderate asthma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof., Head of Department of Immunology and Allergology
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 17, 2020
Study Start
May 1, 2019
Primary Completion
November 1, 2022
Study Completion
April 1, 2024
Last Updated
April 17, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share