NCT04352088

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

3.5 years

First QC Date

April 15, 2020

Last Update Submit

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

Procedure: Nasal provocation test

Allergic rhinitis and asthma patients

Procedure: Nasal provocation test

Healthy individuals

Procedure: Nasal provocation test

Interventions

Allergen extract under controlled conditions will be applied into nasal mucous.

Allergic rhinitis and asthma patientsAllergic rhinitis patientsHealthy individuals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Laura Tamasauskiene, MD

CONTACT

Brigita Sitkauskiene

CONTACT

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

Locations