AzTrials
AzTrials

Type I HypersensitivityPhase 3NCT00414141

Efficacy and Safety/Tolerability of Grass MATA MPL

A Phase 3 study testing Grass MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 94 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Grass MATA MPL has been developed by Allergy Therapeutics (UK) Ltd. to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Type I Hypersensitivity
What is being tested?
Grass MATA MPL
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,028 participants
Where
94 sitesin 4 countries
Study dates
Nov 2006to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Have given written informed consent;
  • 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];
Show all 11Show fewer
  • 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.

Who cannot join

  • Are pregnant or lactating
  • 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;
Show all 42Show fewer
  • 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

Trial locations and contacts

94 sites in 4 countries.

94 sites in 4 countries

United States65 sites

  • MD Office and Research

    Altoona, Pennsylvania, 16601

  • Bellingham Asthma And Allergy Associates

    Bellingham, Washington, 98225

  • Montana Allergy and Asthma 2900 12th Avenue North Suite 302E

    Billings, Montana, 59101

  • Brigham & Women's Hospital, Rheumatology & Immunology, Smith Building Rm 626

    Boston, Massachusetts, 02115

  • Allergy and Respiratory Center

    Canton, Ohio, 44718

  • Asthma Immunology & Allergy

    Chattanooga, Tennessee, 37421

  • Asthma & Allergy Research Assoc Presidents House

    Chester, Pennsylvania, 19013

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Asthma & Allergy Associates, PC & Research Center

    Colorado Springs, Colorado, 80907

  • Asthma and Allergy Associates, PC

    Cortland, New York, 13045

  • Colorado Allergy & Asthma Centers, PC

    Denver, Colorado, 80230

  • Intermountain Clinical Research

    Draper, Utah, 84020

  • Medical Associates Clinic

    Dubuque, Iowa, 52002

  • Asthma and Allergy Associates, PC

    Elmira, New York, 14901

  • Colorado Allergy and Asthma Clinic, PC

    Englewood, Colorado, 80112

  • Allergy & Asthma Research Group

    Eugene, Oregon, 97401

  • Physicians Pharmaceutical Study Services

    Everett, Washington, 98201

  • Allergy & Asthma Care Center

    Fargo, North Dakota, 58103

  • Merit Care Health

    Fargo, North Dakota, 58122

  • The Allergy and Asthma Center

    Fort Wayne, Indiana, 46804

  • "The Allergy & Arthritis Family Treatment Centers

    Gardner, Massachusetts, 01440

  • Allergy Asthma and Sinus Center

    Greenfield, Wisconsin, 53228

  • Penn State University Hershey Medical Center, Dept of Medicine

    Hershey, Pennsylvania, 17033

  • Iowa Clinical Research Corporation

    Iowa City, Iowa, 52240

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • The Allergy, Asthma, and Sinus Center 801 Weisgarber Road

    Knoxville, Tennessee, 37909

  • Allergy, Asthma and Dermatology Research Center, L.L.C.

    Lake Oswego, Oregon, 97035

  • Dean Foundation for Health Research & Education, Inc.Med Reseach Dept.

    Madison, Wisconsin, 53715

  • Allergy & Asthma Center

    Marlboro, New Jersey, 07746

  • Clinical Research Institute of Southern

    Medford, Oregon, 97504

  • Advanced Healthcare Clinical Research Center

    Milwaukee, Wisconsin, 53209

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Montana Medical Research

    Missoula, Montana, 59808

  • Allergy Associates of Utah

    Murray, Utah, 84107

  • Sneeze, Wheeze & Itch Associates

    Normal, Illinois, 61761

  • Midwest Allegy and Asthma Clinic

    Omaha, Nebraska, 68130

  • Creighton University - Allergy & Immunology

    Omaha, Nebraska, 68131

  • Kansas City Allergy and Asthma Associates, PA

    Overland Park, Kansas, 66210

  • Nebraska Medical Research Institute

    Papillion, Nebraska, 68046

  • Clinical Research Source, Inc.

    Perrysburg, Ohio, 43551

  • Allergy and Asthma Research of NJ

    Philadelphia, Pennsylvania, 19115

  • Allergy & Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Clinical Research Institute

    Plymouth, Minnesota, 55441

  • Allergy Associates Research Center, LLC

    Portland, Oregon, 97213

  • Allergy Asthma Immunology Clin RI,Ltd

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Aair Research Center

    Rochester, New York, 14618

  • Island Medical Research, PC

    Rockville Centre, New York, 11570

  • Princeton Center for Clinical Research Montgomery Professional Center

    Skillman, New Jersey, 08558

  • Timber Lane Allergy & Asthma Research, LLC

    South Burlington, Vermont, 05403

  • Clinical Research Specialists of Utah

    Spanish Fork, Utah, 84660

  • Marycliff Allergy Specialists

    Spokane, Washington, 99204

  • Spokane Allergy & Asthma Clinical Research

    Spokane, Washington, 99204

  • McGovern Allergy Associates, PC

    Springfield, Massachusetts, 01103

  • Saint Louis University

    St Louis, Missouri, 63110

  • Toledo Center for Clinical Research

    Sylvania, Ohio, 43560

  • Pulmonary Consultants, P.L.L.C.

    Tacoma, Washington, 98405

  • The Medical Center at Teaneck

    Teaneck, New Jersey, 07666

  • Allergy Consultants, PA

    Verona, New Jersey, 07044

  • Dr. Dreyfus

    Waterbury, Connecticut, 06708-3104

  • Allergic Diseases, SC

    West Allis, Wisconsin, 53227

  • Respiratory Medicine Researdh Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada17 sites

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • Kanata Allergy Services Ltd.

    Kanata, Ontario, K2L 3C8

  • Kelowna Allergy and Respiratory Health Clinic

    Kelowna, British Columbia, V1Y 9L7

  • Omnispec Clinical Research

    Mirabel, Quebec, J7J 2K8

  • Allied Research International

    Mississauga, Ontario, L4W 1N2

  • Alpha Medical Research Inc.

    Mississauga, Ontario, L5B1N1

  • The McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • Niagara Clinical Research

    Niagara Falls, Ontario, L2G 1J4

  • Northgate Medical Clinic

    North Bay, Ontario, P1B 2H3

  • Allergy and Asthma Research Centre

    Ottawa, Ontario, K1Y 4G2

  • Centre De Recherche Appliquée en Allergie De Québec

    Québec, Quebec, GiV 4M6

  • Q&T Research

    Sherbrooke, Quebec, J1H4J6

  • Filderman R.

    Toronto, Ontario, M3H3S3

  • Knight A.

    Toronto, Ontario, M4P 1P2

  • Sussman G.

    Toronto, Ontario, M4V 1R2

  • Manna Research

    Toronto, Ontario, M9W 4L6

Other trials in Canada

United Kingdom8 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Brighton General Hospital Dept. Respiratory Medicine

    Brighton, BN2 3EW

  • Addenbrookes Hospital

    Cambridge, CB2 2QQ

  • Ninewells Hospital and Medical School

    Dundee, DD1 4HN

  • Glenfield Hospital

    Leicester, LE3 9PQ

  • Guys Hospital

    London, SE1 9RT

  • Lung Function - Northwest Lung Center

    Manchester, M23 9LP

  • Southampton General Hospital

    Southampton, SO16 6Y

Other trials in United Kingdom

Austria4 sites

  • Universitätsklinik für Umweltdermatologie

    Graz, 8036

  • Universitätsklinik für Dermatologie und Venerologie

    Innsbruck, 6020

  • Allgemeines Krankenhaus der Stadt Wien - Universitätsklinik für Dermatologie

    Vienna, 1090

  • Allergie-Zentrum Wien West

    Vienna, 1150

Other trials in Austria

About this study

Official title: Efficacy and Safety/Tolerability of Grass MATA MPL, a Randomized, Placebo-Controlled, Double-Blind Study

Grass MATA MPL has been developed by Allergy Therapeutics (UK) Ltd. to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale. 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.

Read the detailed description

Grass MATA MPL has been developed by Allergy Therapeutics (UK9 Ltd.to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale. Grass MATA MPL is produced as a re-formulation of the Allergy Therapeutics product Pollinex Quattro, which has been used in Europe since 1999 on a 'named patient' basis (with approximately 65,000 treatment courses containing grass pollens).

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.

Being tested
Grass MATA MPL, Placebo
Keywords
Allergy, Allergoid, Specific Immunotherapy
Medical subject headings
Hypersensitivity, Immediate, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grass MATA MPLBiological

    4 subcutaneous injections

  • PlaceboBiological

    Also called tyrosine solution

    4 subcutaneous injections

Study groups in NCT00414141
Study groupRoleWhat they receive
1ExperimentalGrass MATA MPL
Receives: Biological: Grass MATA MPL
2Placebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Grass MATA MPL versus placebo measured by combined allergy symptom + medication scores during 4 peak weeks of grass season

    Measured: 9 Months

Secondary outcomes (2)

  1. Combined symptom + medication scores, Combined symptoms, Individual symptoms, Relief medication use, Specific immunological changes, quality of life, Health Assessments, Days absent from activities

    Measured: 9 Months

  2. Adverse events, adverse reactions, clinical labs, ECG, and vitals

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionAug 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00414141
Sponsor's protocol ID
GrassMATAMPL301
Status last verified
Sep 2009
First submitted
20 Dec 2006
Last updated
17 Jun 2010
Results posted
No

Publications

  • 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.

    PubMed 23062390

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Grass MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 94 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Canada, United Kingdom, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Grass MATA MPL versus placebo measured by combined allergy symptom + medication scores during 4 peak weeks of grass season (time frame: 9 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00414141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in