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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT03394508
Eligibility Criteria:
Inclusion Criteria:
* Allergic rhinitis due to grass or birch pollen
* Mild to moderate asthma with a positive methacholine challenge
* Accepted and signed informed consent.
Exclusion Criteria:
* Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
* Previously SCIT but no symptom improvement at all.
* Sensitizations to house dust mite or furry animals, with ongoing exposure and symptoms.
* Severe atopic dermatitis.
* Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
* Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
* Known autoimmune or collagen disease
* Cardiovascular disease
* Hepatic disease
* Known renal insufficiency
* Cancer
* Hematologic disease
* Chronic infectious disease
* Any medication with a possible side-effect of interfering with the immune response
* Previous immuno- or chemotherapy
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
* Major metabolic disease
* Known or suspected allergy to the study product
* Obesity with BMI \> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
* Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
* Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
* Mental incapability of coping with the study
* Withdrawal of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT03394508
Study Brief:
Protocol Section:
NCT03394508