- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422149
Twin SUBLIVAC® Grasses Clinical Efficacy Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Indication under study: IgE mediated allergic disorders triggered by grass pollen.
Number of centres: approximately 50.
Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based on the outcome the study will be stopped or continued for another season.
Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without mild asthma (FEV1 > 70%) related to grass pollen, age 12 years or older.
Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached.
Route of administration: Sublingual application (drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed).
Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2020
- Dr. P. van Durme
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Genk, Belgium, 3600
- Centrum Gespecialiseerde Geneeskunde Genk
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Gent, Belgium, 9000
- UZ Gent, Dienst NKO, 1P1
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Leuven, Belgium, 3000
- UZ Gasthuisberg, Afd. Allergie/Immunologie
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Leuven, Belgium, 3000
- UZ Gasthuisberg, Dienst Kindergeneeskunde
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Leuven, Belgium, 3000
- UZ Gasthuisberg, lokatie St. Rafaël
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Mechelen, Belgium, 2800
- Kinderallergie-Astma kinderz.
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Aachen, Germany, 52074
- Allergologie Aachen
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Berlin, Germany, 10117
- Charité - Universitätsmedizin Berlin
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Berlin, Germany, 13597
- Studienzentrum Berlin
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Braunschweig, Germany, 38100
- Allergologie Braunschweig
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Darmstadt, Germany, 64283
- Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
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Dorsten, Germany, 46284
- Allergologie Dorsten
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Dortmund, Germany, 44388
- Hals, Nasen- u. Ohrenheilkunde Dortmund
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Duisburg, Germany, 47179
- Hals, Nasen- u. Ohrenheilkunde Duisburg
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Düren, Germany, 52351
- Medi-Center Düren
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Düsseldorf, Germany, 40210
- Hals, Nasen- u. Ohrenheilkunde Düsseldorf
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Düsseldorf, Germany, 40225
- Heinrich-Heine-Universität Düsseldorf, Hautklinik
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Erlangen, Germany, 91054
- Universität Erlangen, Poliklinik für Kinder und Jugendliche
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Essen, Germany, 45136
- Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
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Essen, Germany, 45143
- Hals, Nasen- u. Ohrenheilkunde Essen
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Essen, Germany, 45329
- Hals, Nasen- u. Ohrenheilkunde Essen
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Gifhorn-Winkel, Germany, 38518
- Allergologie Gifhorn
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Gütersloh, Germany, 33332
- Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
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Hannover, Germany, 30167
- Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
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Hannover, Germany, 30625
- Med.Hochschule Hannover, Kinderklinik
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Jülich, Germany, 52428
- Allergologie Jülich
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Kassel, Germany, 34117
- Allergologie Kassel
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Krefeld, Germany, 47807
- HNO - Krefeld
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Luedenscheid, Germany, 58511
- Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
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Stockach, Germany, 78333
- Allgemeinmedizin Stockach, Baden
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Ulm, Germany, 89081
- Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
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Wiesbaden, Germany, 65183
- Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
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Willich, Germany, 47877
- Hals, Nasen- u. Ohrenheilkunde Willich
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Wuppertal, Germany, 42103
- Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
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Amersfoort, Netherlands, 3800 BM
- Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
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Arnhem, Netherlands, 6224 BJ
- Allergologen Maatschap Arnhem
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Assen, Netherlands, 9401RK
- Wilhelmina Ziekenhuis Assen, Afdeling KNO
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Schiedam, Netherlands, 3116 BA
- Vlietland Ziekenhuis, lokatie Schiedam, KNO
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Bialystok, Poland, 15-274
- Medical University of Bialystok, Department of Pediatrics and Allergology
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Gdansk, Poland, 80-211
- Medical University of Gdansk, Department of Allergology
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Inowroclaw, Poland, 88-100
- FARMA-MED. Sp. z o. o.
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Kraków, Poland, 31-066
- Jagiellonian University Medical College, Department of Allergy and Immunology
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Kraków, Poland, 31-531
- Jagiellonian University Medical College, Department of Allergology and Dermatology
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Lodz, Poland, 90-553
- NZOZ Centrum Alergologii
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Lodz, Poland, 90-153
- Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
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Lodz, Poland, 91-153
- Medical University of Lodz, Department of Allergology and Pulmonology
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Lodz, Poland, 92-213
- Medical University of Lodz, Department of Clinical Immunology and Allergy
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Lodz, Poland, 93-513
- Medical University of Lodz, Department of Pediatrics and Allergology
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Lublin, Poland, 20-093
- Medical University of Lublin, Department of Allergology and Immunotherapy
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Lublin, Poland, 20-954
- Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
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Pabianice, Poland, 95-200
- Oddzial Dzieciecy SPZOZ
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Rabka Zdrój, Poland, 34-700
- Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
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Sieradz, Poland, 98-200
- Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
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Tomaszów Mazowiecki, Poland, 97-200
- Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
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Warsaw, Poland, 00-909
- Military Institute of the Health Services, Department of Infection Disease and Allergology
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Warsaw, Poland, 00-909
- Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
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Warszawa, Poland, 00-521
- Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
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Wroclaw, Poland, 50-417
- Medical University of Wroclaw, Department of Internal Disease and Allergology
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Zabrze, Poland, 41-800
- Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with allergic rhinoconjunctivitis with or without mild asthma FEV1 ≥ 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the two previous years)
- A positive skin prick test (>3 mm) for early flowering treesgrasses and specific serum IgE-test(>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poa pratensis).
Exclusion Criteria:
- A positive SPT for perennial allergens of house dust mite
- Allergy to any of the excipients
- Symptoms related to concomitant sensitisation to perennial allergens of pets
- Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
- Use of symptomatic medication for more than three episodes and/or longer than three days outside the tree- or grass pollen season
- Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
- Inflammation and infection of the target organ
- Severe atopic dermatitis requiring systemic immuno-suppressive medication
- Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
- History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
- A positive pregnancy test, lactation or inadequate contraceptive measures Alcohol- or drug abuse
- Lack of co-operation or severe psychological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 2
Placebo treatment
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SUBLIVAC® Grasses/Placebo treatment
Placebo treatment
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Active Comparator: 1
SUBLIVAC® Grasses treatment
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SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
Time Frame: June, July, August 2007
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June, July, August 2007
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CIS derived variables
Time Frame: June, July and August 2007
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June, July and August 2007
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RQLQ, quantitative skin prick test
Time Frame: Pollen season 2006 and 2007
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Pollen season 2006 and 2007
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oral allergy syndrome
Time Frame: October 2006 until September 2007
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October 2006 until September 2007
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mast-cell serum tryptase
Time Frame: 6 months therapy
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6 months therapy
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specific immunoglobulins (IgE and IgG).
Time Frame: 6 months therapy
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6 months therapy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: R Peter, Prof.Dr.med, Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Conjunctival Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Conjunctivitis
- Conjunctivitis, Allergic
Other Study ID Numbers
- SG/0021
- EudraCTnr: 2005-005175-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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