Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT02214303
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02214303
Study Brief:
Protocol Section:
NCT02214303