Study Results
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Basic Information
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COMPLETED
PHASE3
1028 participants
INTERVENTIONAL
2006-11-30
2007-11-30
Brief Summary
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Detailed Description
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Grass MATA MPL contains an extract of the 13 grass 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 Grass MATA MPL versus placebo in grass-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 grass pollen season.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Grass MATA MPL
Grass MATA MPL
4 subcutaneous injections
2
Placebo
4 subcutaneous injections
Interventions
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Grass MATA MPL
4 subcutaneous injections
Placebo
4 subcutaneous injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are 18 to 59 years of age;
* Have a history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis ascribed to grass pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers;
* Have a history of moderate to severe symptoms in the past grass pollen season as determined by a score of ≥ 5 on the Disease Severity Questionnaire;
* Have a positive skin prick test to grass pollen mix \[wheal (longest diameter) ≥ 5 mm greater than the negative control\] and a positive RAST or equivalent test (class ≥ 2) to grass pollen mix;
* Have a positive skin prick test to histamine \[wheal (longest diameter) of ≥ 3 mm greater than the negative control\];
* Have a negative skin prick test to the negative control (redness with wheal ≤ 2 mm is acceptable);
* Have a 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 \[i.e. double barrier method of contraception (e.g., intrauterine device and condom, spermicide and condom), stable hormonal contraceptive for ≥ 90 days prior to the study or if \< 90 days additional use of a double barrier method until 90 days reached, sexual abstinence or have a vasectomized partner until study completion\], and have a negative β-HCG pregnancy test result at Visits 1 and 2;
* Are able to understand and comply with study instructions;
* Demonstrate proper use of electronic diary with at least 85% compliance (i.e., correct entries for symptoms on 6 of 7 days) during the 1-week period between Visit 1 and Visit 2.
Exclusion Criteria
* Have asthma requiring the daily use of controller medication;
* Had an emergency room visit or admission for asthma in the 12 months prior to Visit 1;
* Have the presence of secondary alteration at the affected organ (i.e., emphysema, bronchiectasis, nasal polyps, chronic sinusitis);
* Have auto-immune disease (e.g., liver, kidney, thyroid, nervous system);
* Have 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;
* Have a history or presence of diabetes (both insulin dependent and non-dependent), cancer or concomitant illness (e.g., cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic, or psychiatric diseases or disorders) that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this grass immunotherapy;
* Have a history of angioedema;
* Have manifest pulmonary or cardiac insufficiency;
* Have current malignant disease;
* Have disorders of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia);
* Have an acute or chronic infection;
* Have any clinically significant abnormal laboratory value (as determined by the Investigator) at Visit 1;
* Perennial Allergens: Have a positive skin prick test \[wheal (longest diameter) ≥ 3mm greater than the negative control\] at Visit 1 to: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chrysogenum, and Aspergillus fumigatus), or epithelia (cat, dog, and horse). 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. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness; easily tolerated;
* Only for the USA and Canada:Autumn/Winter Flowering Plant Allergens: Have a positive skin prick test \[wheal (longest diameter) ≥ 3mm greater than the negative control\] at Visit 1 to: ragweed (Ambrosia sp.) or mountain cedar/mountain juniper (Juniperus ashei). 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 both 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. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated;
* Springtime Flowering Plant Allergens: Applies only to subjects living in geographic areas where springtime flowering plant season and grass season overlap and/or when treatment phase cannot be completed at least 30 days prior to the start of the springtime flowering plant season. Otherwise, no testing of the following allergens is necessary; Have a positive skin prick test \[wheal (longest diameter) ≥ 3mm greater than the negative control\] at Visit 1 to: birch (Betula sp.), oak (Quercus sp.), sycamore/plane (Platanus sp.), beech (Fagus sp.), ash (Fraxinus sp.), or poplar (Populus sp.). 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. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated;
* Only for the USA and Canada:Summertime Flowering Plant Allergens: Have a positive skin prick test \[wheal (longest diameter) ≥ 3mm greater than the negative control\] at Visit 1 to: Bermuda grass (Cynodon dactylon). 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: the listed allergen must not be tested if it is not common to the Investigator's region. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness; easily tolerated;
* 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 (e.g., anticholinergic agents and tricyclic antidepressants) 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 (e.g., 2 weeks holiday abroad during the time of diary recording);
* 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 (UK) Ltd.
Principal Investigators
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Karl Jürgen Fischer von Weikersthal-Drachenberg, MD
Role: STUDY_CHAIR
Allergy Therapeutics
Locations
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Asthma & Allergy Associates, PC & Research Center
Colorado Springs, Colorado, United States
Colorado Allergy & Asthma Centers, PC
Denver, Colorado, United States
Colorado Allergy and Asthma Clinic, PC
Englewood, Colorado, United States
Dr. Dreyfus
Waterbury, Connecticut, United States
Rush University Medical Center
Chicago, Illinois, United States
Sneeze, Wheeze & Itch Associates
Normal, Illinois, United States
The Allergy and Asthma Center
Fort Wayne, Indiana, United States
Medical Associates Clinic
Dubuque, Iowa, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, United States
Kansas City Allergy and Asthma Associates, PA
Overland Park, Kansas, United States
Brigham & Women's Hospital, Rheumatology & Immunology, Smith Building Rm 626
Boston, Massachusetts, United States
"The Allergy & Arthritis Family Treatment Centers
Gardner, Massachusetts, United States
McGovern Allergy Associates, PC
Springfield, Massachusetts, United States
Respiratory Medicine Researdh Institute of Michigan, PLC
Ypsilanti, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Montana Allergy and Asthma 2900 12th Avenue North Suite 302E
Billings, Montana, United States
Montana Medical Research
Missoula, Montana, United States
Midwest Allegy and Asthma Clinic
Omaha, Nebraska, United States
Creighton University - Allergy & Immunology
Omaha, Nebraska, United States
Nebraska Medical Research Institute
Papillion, Nebraska, United States
Allergy & Asthma Center
Marlboro, New Jersey, United States
Princeton Center for Clinical Research Montgomery Professional Center
Skillman, New Jersey, United States
The Medical Center at Teaneck
Teaneck, New Jersey, United States
Allergy Consultants, PA
Verona, New Jersey, United States
Asthma and Allergy Associates, PC
Cortland, New York, United States
Asthma and Allergy Associates, PC
Elmira, New York, United States
Aair Research Center
Rochester, New York, United States
Island Medical Research, PC
Rockville Centre, New York, United States
Allergy & Asthma Care Center
Fargo, North Dakota, United States
Merit Care Health
Fargo, North Dakota, United States
Allergy and Respiratory Center
Canton, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Allergy & Asthma Research Group
Eugene, Oregon, United States
Allergy, Asthma and Dermatology Research Center, L.L.C.
Lake Oswego, Oregon, United States
Clinical Research Institute of Southern
Medford, Oregon, United States
Allergy Associates Research Center, LLC
Portland, Oregon, United States
MD Office and Research
Altoona, Pennsylvania, United States
Asthma & Allergy Research Assoc Presidents House
Chester, Pennsylvania, United States
Penn State University Hershey Medical Center, Dept of Medicine
Hershey, Pennsylvania, United States
Allergy and Asthma Research of NJ
Philadelphia, Pennsylvania, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Allergy Asthma Immunology Clin RI,Ltd
Providence, Rhode Island, United States
Asthma Immunology & Allergy
Chattanooga, Tennessee, United States
The Allergy, Asthma, and Sinus Center 801 Weisgarber Road
Knoxville, Tennessee, United States
Intermountain Clinical Research
Draper, Utah, United States
Allergy Associates of Utah
Murray, Utah, United States
Clinical Research Specialists of Utah
Spanish Fork, Utah, United States
Timber Lane Allergy & Asthma Research, LLC
South Burlington, Vermont, United States
Bellingham Asthma And Allergy Associates
Bellingham, Washington, United States
Physicians Pharmaceutical Study Services
Everett, Washington, United States
Marycliff Allergy Specialists
Spokane, Washington, United States
Spokane Allergy & Asthma Clinical Research
Spokane, Washington, United States
Pulmonary Consultants, P.L.L.C.
Tacoma, Washington, United States
Allergy Asthma and Sinus Center
Greenfield, Wisconsin, United States
Dean Foundation for Health Research & Education, Inc.Med Reseach Dept.
Madison, Wisconsin, United States
Advanced Healthcare Clinical Research Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Allergic Diseases, SC
West Allis, Wisconsin, United States
Universitätsklinik für Umweltdermatologie
Graz, , Austria
Universitätsklinik für Dermatologie und Venerologie
Innsbruck, , Austria
Allgemeines Krankenhaus der Stadt Wien - Universitätsklinik für Dermatologie
Vienna, , Austria
Allergie-Zentrum Wien West
Vienna, , Austria
Kelowna Allergy and Respiratory Health Clinic
Kelowna, British Columbia, Canada
Hamilton Medical Research Group
Hamilton, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
Kanata Allergy Services Ltd.
Kanata, Ontario, Canada
Allied Research International
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 and Asthma Research Centre
Ottawa, Ontario, Canada
Filderman R.
Toronto, Ontario, Canada
Knight A.
Toronto, Ontario, Canada
Sussman G.
Toronto, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Omnispec Clinical Research
Mirabel, Quebec, Canada
The McGill University Health Centre
Montreal, Quebec, Canada
Centre De Recherche Appliquée en Allergie De Québec
Québec, Quebec, Canada
Q&T Research
Sherbrooke, Quebec, Canada
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Brighton General Hospital Dept. Respiratory Medicine
Brighton, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Ninewells Hospital and Medical School
Dundee, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Guys Hospital
London, , United Kingdom
Lung Function - Northwest Lung Center
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Frew AJ, DuBuske L, Keith PK, Corrigan CJ, Aberer W, Fischer von Weikersthal-Drachenberg KJ. Assessment of specific immunotherapy efficacy using a novel placebo score-based method. Ann Allergy Asthma Immunol. 2012 Nov;109(5):342-347.e1. doi: 10.1016/j.anai.2012.08.013.
Other Identifiers
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GrassMATAMPL301
Identifier Type: -
Identifier Source: org_study_id
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