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:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03931993
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a positive skin prick test for grass pollen allergen.
* Positive skin prick test to positive histamine control
* Negative skin prick test to negative control
* Specific IgE for grass pollen as documented by ImmunoCAP test with class ≥ 2
* A history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis due to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers for relief of symptoms during the last two consecutive seasons prior to the study
* Males or non-pregnant, non-lactating females who are not of child-bearing potential or using effective contraception
* Patients who are normally active and otherwise judged to be in good health
* For patients with a history of asthma, forced expiratory volume in 1 second (FEV1) ≥ 80% of National Health and Nutrition Examination Surveys (NHANES) predicted, with a FEV1/forced vital capacity (FVC) ratio ≥ 70%.
* Able to observe the drug washout times listed in the Prohibited Medications Table below prior to screening
* Patients willing and able to attend required study visits and able to follow the protocol requirements.
* Patients willing and able to give written informed consent.
Exclusion Criteria:
* Symptoms outside the grass pollen season due to a perennial and/or non-grass seasonal allergen, if the patient is unable to avoid the offending allergen.
* Immunological disorders or other diseases that in the opinion of the investigator may pose a safety risk.
* Presence of moderate to severe asthma, characterized by the current use of inhaled steroids at a daily dose above 400 micrograms of budesonide (or equivalent)
* Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever.
* Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
* Presence of any skin conditions (skin abnormalities, tattoos etc.) which might interfere with the interpretation of the SPT results.
* Current diagnosis of type I diabetes. Patients with type II diabetes will only be allowed to participate at the discretion of the investigator.
* Treatment with a preparation containing MPL (e.g. Cervarix) within 6 months prior to screening
* Moderate to severe upper or lower respiratory tract infections requiring medication within 14 days of or a diagnosis of sinusitis within 30 days of randomisation
* Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis.
* Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication.
* Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria.
* Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated).
* Clinical history of immunodeficiency, including those who are on immunosuppressant therapy.
* Clinical history of recurrent idiopathic angioedema.
* Beta-blocker medication, including eye drops, for any indication.
* Treatment with monoamine oxidase inhibitors, tricyclic antidepressants or ACE inhibitors.
* Clinical history of drug or alcohol abuse which, in the investigator's opinion, could interfere with the patient's ability to participate in the study.
* Participation in a clinical research trial with any investigational medicinal product within 4 weeks of screening or concomitantly with this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03931993
Study Brief:
Protocol Section:
NCT03931993