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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04542902
Eligibility Criteria:
Inclusion Criteria:
* Men and women between the ages of 18-70 years;
* Allergic asthma and sensitization to house dust mites (D. pteronyssinus) allergen, approved with: 1) medical history and symptoms more than one year; 2) skin prick test positive for D. pteronyssinus (positive wheals are those exceeding 3 mm in diameter greater than the negative control); 3) positive bronchial challenge with methacholine or documented reversible bronchial obstruction;
* Severe eosinophilic asthma;
* Premenopausal women if pregnancy test is negative;
* Healthy subjects without allergic and other chronic respiratory diseases (control group);
* Participants who gave his/her informed written consent.
Exclusion Criteria:
* Asthma exacerbation 1 month prior to study;
* Clinically significant permanent allergy symptoms (ex. cat or dog dander induced allergy);
* Contraindications to perform an allergy skin test and/or bronchial provocation test: 1) active airway infection 1 month prior the study; 2) used medicaments: inhaled glucocorticoids intake 1 month prior the study, 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;
* Contraindications for epinephrine;
* Other significant mental and / or internal diseases and conditions, which could be as exclusion criteria due to the opinion of the researcher;
* Alcohol or narcotic abuse;
* Pregnancy;
* Breast-feeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04542902
Study Brief:
Protocol Section:
NCT04542902