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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT01997606
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be willing to give/sign informed consent
* Subjects (male or female) must be at least 18 years old and maximum 65 years old at screening
* Clinical history of allergic rhinitis for at least 1 year
* Positive skin prick test for D. Pteronyssinus ± D. Farinae
* Positive nasal provocation test with the house-dust-mite allergen
* Specific IgE: Unicap positive to D. Pteronyssinus (d1) and D. Farinae (d2) (\> 0.7U/ml)
* VAS score for global discomfort caused by nasal- or other allergic symptoms during the previous 4 weeks ≥ 5.
* The concentration of Der p1 in the dust collected from own bedding (mattress and pillow), measured by ELISA is above the detection limit (≥ 0.488 ng/ml).
Exclusion Criteria:
* Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals: positive SPT to pets and pets at home
* Patients with an allergy to tree pollen (symptoms during the season + positive skin prick test) should not be included
* Subject pregnant or lactating
* Completed allergen specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
* SCIT or SLIT during the study period
* Regular use of oral corticosteroids for exacerbations of asthma
* Daily use of oral corticosteroids
* Daily use of cyclosporine or other immunosuppressant drugs
* Regular use of antibiotics
* History of anaphylactic reaction to an allergen
* Severe general diseases (especially cardiopulmonary disease with reduced lung capacity)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01997606
Study Brief:
Protocol Section:
NCT01997606