Study Results
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Basic Information
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COMPLETED
PHASE3
993 participants
INTERVENTIONAL
2007-03-31
2008-03-31
Brief Summary
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Detailed Description
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An earlier formulation of Ragweed MATAMPL developed by Allergy Therapeutics (UK), Ltd, available commercially in Canada since the 1980's, is 'Pollinex®-R'. 'Pollinex®-R' is formulated with modified allergens (allergoids) of ragweed pollen extract adsorbed onto L tyrosine at 4% w/v. Related formulations developed by ATL, available commercially in selected European countries since the 1970´s on a Named Patient Basis, are 'Pollinex Tree', 'Pollinex Grass', 'Pollinex Quattro Trees' (previously known as MATA tree + MPL), and 'Pollinex Quattro Grass' (previously known as MATA grass + MPL).
Ragweed MATAMPL contains an extract of ragweed pollens. This extract is chemically modified with glutaraldehyde to produce the active ingredient, an allergoid. Such modification reduces the reactivity of the extract with IgE antibody. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivity is not seen. The modified extract is adsorbed to L-tyrosine as a depot formulation. MPL®, a purified, detoxified glycolipid derived from the cell walls of Salmonella minnesota, is also included in the current product formulation. This excipient/adjuvant is included to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to TH1-like T cell profile.
The current formulation is designed to provide a product that will be efficacious with only 4 injections, in contrast to the longer schedules currently in use with unmodified extracts. The product will also be safer to use than a formulation containing a similar mass of unmodified allergen extract as regards its ability to cause severe local allergic reactions or anaphylaxis, because of its reduced reactivity with IgE antibody. The modification is greater than 75%, so that only a small amount of unmodified allergen is remaining in the product.
The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 ragweed pollen season.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ragweed MATA MPL
modified Ragweed pollen allergen absorbed to Tyrosine and containing MPL adjuvant
Ragweed MATA MPL
4 injections of increasing dose strength:
1. 300 SU/0.5 ml
2. 700 SU/0.5 ml
3. 2000 SU/0.5 ml
4. 6000 SU/0.5 ml
Placebo
4 injections of placebo 0.5 ml (2% tyrosine)
Ragweed MATA MPL
4 injections of increasing dose strength:
1. 300 SU/0.5 ml
2. 700 SU/0.5 ml
3. 2000 SU/0.5 ml
4. 6000 SU/0.5 ml
Interventions
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Ragweed MATA MPL
4 injections of increasing dose strength:
1. 300 SU/0.5 ml
2. 700 SU/0.5 ml
3. 2000 SU/0.5 ml
4. 6000 SU/0.5 ml
Eligibility Criteria
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Inclusion Criteria
* Are 18 to 59 years of age;
* history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis ascribed to ragweed pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers;
* history of moderate to severe symptoms in the past ragweed pollen season;
* positive skin prick test to ragweed pollen and a positive RAST or equivalent test to ragweed pollen;
* positive skin prick test to histamine;
* negative skin prick test to the negative control;
* forced expiratory volume in 1 second (FEV1) ≥ 80% of predicted, with a FEV1/FVC ratio ≥ 70%;
* Women of childbearing potential must be using a medically acceptable method of birth control;
* able to understand and comply with study instructions;
* Demonstrate proper use of electronic diary with at least 85% compliance during the 1-week period between Visit 1 and Visit 2.
Exclusion Criteria
* asthma requiring the daily use of controller medication;
* emergency room visit or admission for asthma in the 12 months prior to Visit 1;
* presence of secondary alteration at the affected organ (i.e., emphysema, bronchiectasis, nasal polyps, chronic sinusitis);
* auto-immune disease;
* acute or subacute (historic) atopic dermatitis, chronic dermatitis, urticaria factitia, and/or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of the skin prick test results;
* history or presence of diabetes, cancer or concomitant illness that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this ragweed immunotherapy;
* history of angioedema;
* manifest pulmonary or cardiac insufficiency;
* current malignant disease;
* disorders of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia);
* acute or chronic infection;
* any clinically significant abnormal laboratory value at Visit 1;
* Perennial Allergens: positive skin prick test at Visit 1 to: house dust mites, molds, or epithelia. In these cases, a careful history is to be taken and if moderate or severe symptoms are reported when exposed to the aforementioned allergens, the subject is to be excluded. Exception: the source of the allergen (cat, dog, horse) can be avoided for the entire study.
* Springtime Flowering Plant Allergens: positive skin prick test at Visit 1 to birch, oak, sycamore, ash, red maple, black walnut, American elm, or poplar. In these cases, a careful history is to be taken and if moderate to severe symptoms are reported when exposed to the aforementioned allergens the subject is to be excluded. Exception: one or all of the listed allergens must not be tested if they are not common to the Investigator's region or, if common to the region, the treatment phase of the study can be initiated at least 30 days after the end of the allergen(s) season or treatment can be completed 30 days before the anticipated start of the allergen(s) season.
* Summertime Flowering Plant Allergens: positive skin prick test at Visit 1 to grass pollen mix or Bermuda grass. In these cases, a careful history is to be taken and if moderate to severe symptoms are reported when exposed to the aforementioned allergens the subject is to be excluded. Exception: No testing is required if there is no overlap between grass / Bermuda grass and ragweed season and if treatment can be completed 30 days before the start of grass / Bermuda grass season. Bermuda grass must not be tested if it is not common to the Investigator's region.
* Late Summer/Autumn Flowering Plant Allergens: positive skin prick test at Visit 1 to: goosefoot/lamb's quarters, firebush/kochia, or English plantain. In these cases, a careful history is to be taken and if moderate to severe symptoms are reported when exposed to the aforementioned allergens the subject is to be excluded. Exception: some or all of the listed allergens must not be tested if they are not common to the Investigator's region.
* Have inadequate washout period prior to screening (Visit 1). The following washout periods prior to Visit 1 are acceptable:
* Oral or parenteral corticosteroids (1 month)
* Inhaled, ocular or intranasal corticosteroids (1 day)
* Mast cell stabilizers (7 days)
* Intranasal or systemic decongestants including cold preparations (1 day)
* Leukotriene modifiers (7 days)
* Afrin (oxymetazoline hydrochloride) (14 days)
* Antihistamines
* Once-daily or twice-daily antihistamines (7 days)
* Short-acting 3 or 4 times a day antihistamines (3 days)
* Hydroxyzine (14 days)
* H2-blockers (1 day)
* Other anti-inflammatory, anti-allergy, and any other medications which, in the opinion of the Investigator, may interfere with the study objectives should be considered on a case-by-case basis
* Topical skin medications on the forearms (14 days);
* Require use of beta blockers;
* Are unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated);
* Have a history of anaphylactic reactions to foods, insect venom, exercise, or drugs;
* Have been treated with a preparation containing MPL® within 6 months prior to Visit 1;
* Have diseases with a pathogenesis interfering with the immune response, and who have received medication which could interfere with the results of the study;
* Have a history of allergy, hypersensitivity or intolerance to the excipients of the study medication;
* Have a history of allergy, hypersensitivity or intolerance to study relief medication;
* Have already undergone hyposensitisation therapy with comparable allergen extracts; An exception will be allowed if prior immunotherapy with comparable allergen was successful, symptoms reappeared some time after stopping the immunotherapy, and the immunotherapy was completed ≥ 3 years before Visit 1;
* Have participated in a clinical research trial with a new chemical substance within 4 weeks of Visit 1;
* Are unable or unwilling to cooperate with the Investigator and to comply with the protocol requirements, or not likely to complete the observation periods sufficiently;
* Have changed residence between geographical regions within the past 3 months
18 Years
59 Years
ALL
No
Sponsors
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Allergy Therapeutics
INDUSTRY
Responsible Party
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Allergy Therapeutics
Principal Investigators
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Karl Jürgen Fischer von Weikersthal-Drachenberg, MD
Role: STUDY_CHAIR
Allergy Therapeutics
Locations
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The Centre for Allergy, Asthma & Immunology
Waterbury, Connecticut, United States
Allergy & Asthma Consultants
Atlanta, Georgia, United States
Clinical Research Atlanta
Atlanta, Georgia, United States
DataQuest Medical Research
Conyers, Georgia, United States
Northeast Georgia Research Center LLC
Gainesville, Georgia, United States
Allergy and Consultants, PC
Lilburn, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
University Consultants in Allergy/Immunlogy
Chicago, Illinois, United States
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, United States
Kansas City Allergy & Asthma
Overland, Kansas, United States
Allergy & Arthritis Treatment Centre
Gardner, Massachusetts, United States
Respiratory Medical Research Institute of Michigan
Ypsilanti, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research Institute/West Health Building
Plymouth, Minnesota, United States
The Clinical Research Center, LLC
St Louis, Missouri, United States
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, United States
Creighton University Medical Center Division of Allergy, Asthma and Immunology
Omaha, Nebraska, United States
The Asthma and Allergy Centre
Papillion, Nebraska, United States
Atlantic Research Center LLC
Ocean City, New Jersey, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
Pulmonary & Allergy Associates, P.A.
Summit, New Jersey, United States
The Medical Center at Teaneck
Teaneck, New Jersey, United States
AAIR Research Center
Rochester, New York, United States
Ira Finegold, M.D.
White Plains, New York, United States
Regional Allergy & Asthma Consultants
Asheville, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Allergy & Asthma Care Centre
Fargo, North Dakota, United States
Allergy & Respiratory Center
Canton, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Dr. Jeffrey Rosch Office and Research Centre
Altoona, Pennsylvania, United States
Valley Clinical Research Centre
Easton, Pennsylvania, United States
Allergy and Asthma Research of New Jersey Inc.
Philadelphia, Pennsylvania, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Asthma and Allergy Associates
Upland, Pennsylvania, United States
Tricities Medical Research
Bristol, Tennessee, United States
The Asthma Institute, PLLC
Chattanooga, Tennessee, United States
The Allergy, Asthma & Sinus Centre PA
Knoxville, Tennessee, United States
Clinical Research Associates, Inc
Nashville, Tennessee, United States
Allergy & Asthma Associates Research Department
Austin, Texas, United States
Lovelace Scientific Resources Allergy and Asthma Centre of Austin
Austin, Texas, United States
AARA Research Centre
Dallas, Texas, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States
Allergy & Asthma Associates
Houston, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Diagnostic Research Group
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Allergy & Asthma Care of Waco
Waco, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Timber Lane Allergy & Asthma Research
South Burlington, Vermont, United States
Commonwealth Clinic Research Specialists Inc.
Richmond, Virginia, United States
National Clinical Research
Richmond, Virginia, United States
Allergy, Asthma & Sinus Centre, S.C.
Greenfield, Wisconsin, United States
Dean Foundation Medical Research
Madison, Wisconsin, United States
University of Wisconsin, Madison, School of Medicine and Public Health
Madison, Wisconsin, United States
Centre For Clinical Trials
Menomonee Falls, Wisconsin, United States
Advanced Healthcare SC
Milwaukee, Wisconsin, United States
Allergic Diseases SC
West Allis, Wisconsin, United States
JBN Medical Diagnostic Services Inc.
Burlington, Ontario, Canada
Co-Medica Health Centre
Courtice, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
Kanata Allergy Services Ltd.
Kanata, Ontario, Canada
Allied Research International Inc
Mississauga, Ontario, Canada
Alpha Medical Research Inc.
Mississauga, Ontario, Canada
Niagara Clinical Research
Niagara Falls, Ontario, Canada
Northgate Medical Clinic
North Bay, Ontario, Canada
Allergy & Asthma Research Centre
Ottawa, Ontario, Canada
Melimar Allergy Laboratory Inc.
Toronto, Ontario, Canada
Asthma, Allergy & Immunology
Toronto, Ontario, Canada
Gordon Sussman, 202 St. Clair Avenue West
Toronto, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Omnispec Clinical Research
Mirabel, Quebec, Canada
Division of Clinical Immunology and Allergy, The McGill University Health Centre
Montreal, Quebec, Canada
Centre De Recherche Appliquée en Allergie De Quebec
Québec, Quebec, Canada
Q&T Research
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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RagweedMATAMPL301
Identifier Type: -
Identifier Source: org_study_id
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