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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT00133159
Eligibility Criteria:
Inclusion Criteria:
* positive skin prick test for grass and rye allergen
* Specific IgE for grass and rye as documented by radioallergosorbent or equivalent test with class \>= 2
* History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass and rye
* Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method.
* Spirometry at Screening demonstrates FEV1 \>= 80% predicted and FEV1/FVC \>= 70%
Exclusion Criteria:
* Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
* Patient has moderate to severe asthma
* Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
* History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
* Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
* Any clinically significant (as determined by the investigator) abnormal laboratory value
* Perennial allergens: clinically relevant sensitivity against house dust mites, molds, and epithelia
* Patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Bermuda grass, or ragweed.
* Secondary alteration at the affected organ
* History of autoimmune diseases and/or rheumatoid diseases
* Patient is taking b-blockers
* Patient who is not allowed to receive adrenalin
* Patients in whom tyrosine metabolism is disturbed
* Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study
* Documented evidence of acute or significant chronic infection
* History of anaphylaxis
* Documented history of angioedema
* Hypersensitivity to excipients in the study medications
* Previous or current immunotherapy with comparable grass/rye allergen extracts
* Currently using anti-allergy medication and other drugs with antihistaminic activity
* Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days
* Patient is pregnant or planning pregnancy and/or lactating
* Patient has received treatment with preparation containing MPL® during the past 12 months
* Any systemic disorder that could interfere with the evaluation of the study medication(s)
* Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00133159
Study Brief:
Protocol Section:
NCT00133159