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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02214303
• Date of registration: 06/08/2014
• Prospective Registration: No
• Primary sponsor: Lithuanian University of Health Sciences
• Public title: The Role of Th9 Cells and Eosinophils Activity in Allergic Airway Diseases SAIRA
• Scientific title: The Role of Th9 Cells Expression and Eosinophils Activity in the Course of Allergic Airway Diseases
• Date of first enrolment: April 2013
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02214303
• Study type: Observational
• Study design: Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Lithuania

Contacts

• Name: Raimundas Sakalauskas, prof., dr.

• Name: Raimundas Sakalauskas, prof., dr.

• Name: Raimundas Sakalauskas, Prof., dr.
• Affiliation: Lithuanian University of Health Sciences, Pulmonology and Immunology department

Key inclusion & exclusion 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 ß2 agonists 12 hours prior the study;

4. Long acting ß2 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergic Rhinitis

Allergic Asthma

Primary Outcome(s)

Th9 cells and eosinophil apoptosis [Time Frame: 24 hours after bronchial allergen challenge]

Secondary ID(s)

SAIRA-1017/2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors