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

NCT ID: NCT02214303

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Allergic Asthma; Allergic Rhinitis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Allergic asthma

Allergic asthma (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)

No interventions assigned to this group

Allergic rhinitis

allergic rhinitis patients (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)

No interventions assigned to this group

Control group

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Raimundas Sakalauskas

prof., dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raimundas Sakalauskas, Prof., dr.

Role: STUDY_CHAIR

Lithuanian University of Health Sciences, Pulmonology and Immunology department

Locations

Lithuanian University of Health Sciences

Kaunas, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Raimundas Sakalauskas, prof., dr.

Role: CONTACT

raimundas.sakalauskas@kaunoklinikos.lt

376953 ext. +370

Deimante Hoppenot, MD

Role: CONTACT

deimante@gmail.com

67439677 ext. +370

Facility Contacts

Raimundas Sakalauskas, prof., dr.

Role: primary

raimundas.sakalauskas@kaunoklinikos.lt

37326953 ext. +370

Deimante Hoppenot, MD

Role: backup

deimante@gmail.com

67439677 ext. +370

References

Hoppenot D, Malakauskas K, Lavinskiene S, Sakalauskas R. p-STAT6, PU.1, and NF-kappaB are involved in allergen-induced late-phase airway inflammation in asthma patients. BMC Pulm Med. 2015 Oct 14;15:122. doi: 10.1186/s12890-015-0119-7.

Reference Type: DERIVED

PMID: 26466682 (View on PubMed)

Other Identifiers

SAIRA-1017/2012

Identifier Type: -

Identifier Source: org_study_id