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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT01918956
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent.
* Age ≥12 years.
* Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
* FEV1\>70% for patients with a history of mild to moderate asthma, FEV1\>70% or PEF\>80% for patients without a history of asthma
* A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen.
* Positive serum specific anti-birch IgE-test (\>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization.
Exclusion Criteria:
* Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
* Any specific immunotherapy (SCIT or SLIT) during the study period
* Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
* Active malignancies or any malignant disease within the past 5 years
* Severe uncontrolled diseases that could increase the risk for patients participating in the study
* Acute/active inflammation or infection of the target organs at the start of the study
* Secondary changes of the target organ
* Diseases with a contraindication for the use of adrenaline
* Use of systemic steroids within 4 weeks before start of the study and during the study
* Treatment with systemic and local β-blockers
* Vaccination within one week before start of therapy or during the initiation phase
* Anti-IgE therapy within the 6 months prior to inclusion and during the study
* Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
* Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age
* Alcohol, drug or medication abuse within the past year
* Any clinically significant abnormal laboratory parameter at screening
* Lack or expected lack of cooperation or compliance
* Severe psychiatric, psychological, or neurological disorders
* Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01918956
Study Brief:
Protocol Section:
NCT01918956