Status:
COMPLETED
Investigation of Efficacy and Safety of Ragweed MATAMPL, Pollinex-R and Placebo in Patients With Ragweed Allergy
Lead Sponsor:
Allergy Therapeutics
Conditions:
Type I Hypersensitivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed pollen (hay fever). This novel formulation is designed to provide a vacc...
Detailed Description
Allergic rhinitis is a nasal inflammatory disorder initiated by an immunoglobulin-E (IgE) mediated hypersensitivity to allergens. This condition is characterized by sneezing, rhinorrhea, nasal itching...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00110786
Start Date
May 1 2005
End Date
December 1 2005
Last Update
June 17 2010
Active Locations (1)
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1
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2