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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01059266
Eligibility Criteria:
Inclusion Criteria
* Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years related to grass pollen, eligible for SCIT.
* Confirmation of IgE-mediated allergy by means of:
* Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or
* Specific serum IgE-test (ssIgE \>0.7 U/ml) for grass pollen, or
* Positive provocation test for grass pollen.
* Age ≥ 18 years.
* Patients have given a written informed consent
Exclusion Criteria:
* Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.
* Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
* Active inflammation/infection of the target organs (nose, eyes, lungs).
* Severe atopic dermatitis in need for systemic immunosuppressive medication.
* Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.
* Severe kidney disease.
* Diseases with a contra-indication for the use of adrenaline.
* Treatment with systemic or local beta-blockers or immunosuppressive drugs.
* History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
* Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months.
* Participation in a clinical study with a new investigational drug within the last three months.
* Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man).
* Alcohol or drug abuse.
* Lack of co-operation or severe psychological disorders.
* Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
* Low compliance or inability to understand instructions/study documents.
* Completed or ongoing treatment with anti-IgE-antibody.
* Patients being in relationship or dependence with the sponsor or investigator.
* Allergy to any of the excipients.
* Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01059266
Study Brief:
Protocol Section:
NCT01059266