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The Role of Th9 Cells and Eosinophils Activity in Allergic Airway Diseases (SAIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214303
Recruitment Status : Unknown
Verified August 2014 by Raimundas Sakalauskas, Lithuanian University of Health Sciences.
Recruitment status was:  Recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Raimundas Sakalauskas, Lithuanian University of Health Sciences

Brief Summary:
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.

Condition or disease
Allergic Asthma Allergic Rhinitis

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: The Role of Th9 Cells Expression and Eosinophils Activity in the Course of Allergic Airway Diseases
Study Start Date : April 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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)
Control group
Healthy subjects



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Induced sputum and peripheral blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Allergic asthma
Criteria

I. Inclusion criteria:

  1. Men and women between the ages of 18-50 years;
  2. Allergic asthma (skin prick test positive for D. pteronyssinus, 5 grass mixture or birch pollen);
  3. Symptoms more than one year;
  4. Positive Bronchial challenge with methacholine or documented completely reversible bronchial obstruction;
  5. Stable lung function (FEV1≥70 perc.);
  6. Allergic rhinitis diagnosed according ARIA criteria.
  7. Postmenopausal women. Premenopausal women if pregnancy test is negative
  8. Healthy (subjects who are not sick with acute or chronic inflammatory, infectious, oncologic or immune diseases) - control group
  9. Participants who gave his/her informed written consent.

II. Exclusion criteria

  1. Asthma and rhinitis exacerbation;
  2. Clinically significant permanent allergy symptoms (ex. cat or dog dander induced allergy);
  3. Active airway infection 1 month prior the study;
  4. Used medicaments:

    1. Inhaled glucocorticoids intake 1 month prior the study;
    2. Antihistamines intake 7 days prior the study;
    3. Short acting β2 agonists 12 hours prior the study;
    4. Long acting β2 agonists 2 days prior the study;
    5. Leukotriene receptor antagonists prior 14 days;
  5. If the histamine mean wheal diameter is <= 3 mm or control mean wheal diameter is >= 3 mm;
  6. Psychiatric disorders;
  7. Alcohol or narcotic abuse;
  8. Pregnancy.
  9. Breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214303


Contacts
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Contact: Raimundas Sakalauskas, prof., dr. 376953 ext +370 raimundas.sakalauskas@kaunoklinikos.lt
Contact: Deimante Hoppenot, MD 67439677 ext +370 deimante@gmail.com

Locations
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Lithuania
Lithuanian University of Health Sciences Recruiting
Kaunas, Lithuania, 50009
Contact: Raimundas Sakalauskas, prof., dr.    37326953 ext +370    raimundas.sakalauskas@kaunoklinikos.lt   
Contact: Deimante Hoppenot, MD    67439677 ext +370    deimante@gmail.com   
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Study Chair: Raimundas Sakalauskas, Prof., dr. Lithuanian University of Health Sciences, Pulmonology and Immunology department

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raimundas Sakalauskas, prof., dr., Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02214303    
Other Study ID Numbers: SAIRA-1017/2012
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014
Keywords provided by Raimundas Sakalauskas, Lithuanian University of Health Sciences:
Allergic asthma
Allergic rhinitis
Healthy subjects
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases