Investigation of Efficacy and Safety of Ragweed MATAMPL, Pollinex-R and Placebo in Patients With Ragweed Allergy
Type I Hypersensitivity
About this trial
This is an interventional treatment trial for Type I Hypersensitivity focused on measuring Allergy, Specific Immunotherapy, Ragweed, Environmental Exposure Chamber
Eligibility Criteria
Inclusion Criteria: at least a 2-year clinical history of seasonal allergic rhinitis allergy to a ragweed allergen, defined by positive case history and positive skin prick test Specific IgE for ragweed as documented by a radioallergosorbent test (RAST), or equivalent test, with class >= 2 minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure at both Visits 4 and 5. Patients must observe drug washout times listed in the protocol prior to Screening. Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile Females of childbearing potential should be using acceptable birth control methods Patients who are normally active and otherwise judged to be in good health Patients must be willing and able to give written informed consent and must provide this consent Patients must be willing and able to attend required study visits Patients must be able to follow instructions Exclusion Criteria: Symptomatic for allergic rhinitis or allergic conjunctivitis from allergy to grass or trees Symptomatic for significant perennial rhinitis Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications Concurrent use of any prohibited medication(s) or inadequate washout of medication Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids Chronic use of long acting antihistamines and other concomitant medications that would affect assessment of the effectiveness of study drug(s) Any systemic disorder that could interfere with the evaluation of the study medication(s) Upper or lower respiratory infection requiring antibiotics within 14 days of the first Baseline EEC Visit Diagnosis of sinusitis within 30 days of the first Baseline EEC Visit Any ocular disorder (other than allergic conjunctivitis) which could interfere with the evaluation of the study medication Hypersensitivity to the study drug excipients active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex nasal septal ulcers, nasal surgery or nasal trauma within 90 days of enrollment Clinical history of anaphylaxis Patients with contraindications for allergy vaccines Clinical history of immunodeficiency, including immunosuppressant therapy Patients in whom tyrosine metabolism is disturbed Patients with contraindications to adrenaline Subject is taking β-blockers Current diagnosis of chickenpox or measles Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study Clinical history of severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could be expected to interfere with the study Clinical history, or evidence, of nasolacrimal drainage system malfunction Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol Patient that has received Ragweed MATAMPL in any previous clinical trial History of immunotherapy with ragweed pollen extract Patient received treatment with preparation containing MPL during the past 12 months Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study
Sites / Locations
- Allied Research International Inc.