- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214303
The Role of Th9 Cells and Eosinophils Activity in Allergic Airway Diseases (SAIRA)
August 10, 2014 updated by: Raimundas Sakalauskas, Lithuanian University of Health Sciences
The Role of Th9 Cells Expression and Eosinophils Activity in the Course of Allergic Airway Diseases
The prevalence of allergic diseases, especially airway allergic diseases, has increased dramatically over the last twenty years all over the world including Lithuania.
Allergic diseases are associated with significantly reduced quality of life and can sometimes cause death.
Allergic diseases have turned into an important economic and social burden and nowadays take a more and more important place in the health system.
Despite all intensive investigations, the pathogenesis of allergic airway diseases still remains unclear.
As allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to investigate not individual cells, but examine various inflammatory cells instead, including their biological products and possible cellular interactions along the course of allergic diseases.
This research focuses on the cells that are claimed to be important in the pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell, eosinophil.
This study aims at determining the importance the way the Th9 lymphocytes perform, the eosinophil's activity, as well as molecular factors affecting these cells has in the process of prognostication of allergic airway diseases, namely allergic rhinitis and allergic asthma.
An allergen challenge test will be performed in order to define the meaning of pathogenetic changes.
The results of this research may reveal useful information in the course of allergic diseases and may be valuable when creating strategic principles of prophylaxis.
The findings could be used for prevention and early diagnostics of allergic diseases and it could also open doors to discovering new and effective treatment.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
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
- Name: Raimundas Sakalauskas, prof., dr.
- Phone Number: +370 376953
- Email: raimundas.sakalauskas@kaunoklinikos.lt
Study Contact Backup
- Name: Deimante Hoppenot, MD
- Phone Number: +370 67439677
- Email: deimante@gmail.com
Study Locations
-
-
-
Kaunas, Lithuania, 50009
- Recruiting
- Lithuanian University of Health Sciences
-
Contact:
- Deimante Hoppenot, MD
- Phone Number: +370 67439677
- Email: deimante@gmail.com
-
Contact:
- Raimundas Sakalauskas, prof., dr.
- Phone Number: +370 37326953
- Email: raimundas.sakalauskas@kaunoklinikos.lt
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Allergic asthma
Description
I. Inclusion criteria:
- Men and women between the ages of 18-50 years;
- Allergic asthma (skin prick test positive for D. pteronyssinus, 5 grass mixture or birch pollen);
- Symptoms more than one year;
- Positive Bronchial challenge with methacholine or documented completely reversible bronchial obstruction;
- Stable lung function (FEV1≥70 perc.);
- Allergic rhinitis diagnosed according ARIA criteria.
- Postmenopausal women. Premenopausal women if pregnancy test is negative
- Healthy (subjects who are not sick with acute or chronic inflammatory, infectious, oncologic or immune diseases) - control group
- Participants who gave his/her informed written consent.
II. Exclusion criteria
- Asthma and rhinitis exacerbation;
- Clinically significant permanent allergy symptoms (ex. cat or dog dander induced allergy);
- Active airway infection 1 month prior the study;
Used medicaments:
- Inhaled glucocorticoids intake 1 month prior the study;
- Antihistamines intake 7 days prior the study;
- Short acting β2 agonists 12 hours prior the study;
- Long acting β2 agonists 2 days prior the study;
- Leukotriene receptor antagonists prior 14 days;
- If the histamine mean wheal diameter is <= 3 mm or control mean wheal diameter is >= 3 mm;
- Psychiatric disorders;
- Alcohol or narcotic abuse;
- Pregnancy.
- Breast-feeding.
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
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Control group
Healthy subjects
|
Allergic asthma
Allergic asthma (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)
|
Allergic rhinitis
allergic rhinitis patients (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Th9 cells and eosinophil apoptosis
Time Frame: 24 hours after bronchial allergen challenge
|
Blood and sputum eosinophils also peripheral blood th9 cells will be investigated.
|
24 hours after bronchial allergen challenge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Raimundas Sakalauskas, Prof., dr., Lithuanian University of Health Sciences, Pulmonology and Immunology Department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2013
Primary Completion (Anticipated)
September 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 6, 2014
First Submitted That Met QC Criteria
August 10, 2014
First Posted (Estimate)
August 12, 2014
Study Record Updates
Last Update Posted (Estimate)
August 12, 2014
Last Update Submitted That Met QC Criteria
August 10, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAIRA-1017/2012
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
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationCompletedAllergy | Perennial Allergic Rhinitis | Seasonal Allergic RhinitisUnited States
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsCompletedAllergic Rhinitis | Perennial Allergic Rhinitis | Non-seasonal Allergic RhinitisKorea, Republic of
-
United Allergy ServicesCompletedPerennial Allergic Rhinitis With Seasonal VariationUnited States