Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Twin SUBLIVAC® Grasses Clinical Efficacy Study
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
Status | Completed |
Enrollment | 350 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Dr. P. van Durme | Antwerp | |
Belgium | Centrum Gespecialiseerde Geneeskunde Genk | Genk | |
Belgium | UZ Gent, Dienst NKO, 1P1 | Gent | |
Belgium | UZ Gasthuisberg, Afd. Allergie/Immunologie | Leuven | |
Belgium | UZ Gasthuisberg, Dienst Kindergeneeskunde | Leuven | |
Belgium | UZ Gasthuisberg, lokatie St. Rafaël | Leuven | |
Belgium | Kinderallergie-Astma kinderz. | Mechelen | |
Germany | Allergologie Aachen | Aachen | |
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Studienzentrum Berlin | Berlin | |
Germany | Allergologie Braunschweig | Braunschweig | |
Germany | Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie | Darmstadt | |
Germany | Allergologie Dorsten | Dorsten | |
Germany | Hals, Nasen- u. Ohrenheilkunde Dortmund | Dortmund | |
Germany | Hals, Nasen- u. Ohrenheilkunde Duisburg | Duisburg | |
Germany | Medi-Center Düren | Düren | |
Germany | Hals, Nasen- u. Ohrenheilkunde Düsseldorf | Düsseldorf | |
Germany | Heinrich-Heine-Universität Düsseldorf, Hautklinik | Düsseldorf | |
Germany | Universität Erlangen, Poliklinik für Kinder und Jugendliche | Erlangen | |
Germany | Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos | Essen | |
Germany | Hals, Nasen- u. Ohrenheilkunde Essen | Essen | |
Germany | Hals, Nasen- u. Ohrenheilkunde Essen | Essen | |
Germany | Allergologie Gifhorn | Gifhorn-Winkel | |
Germany | Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis | Gütersloh | |
Germany | Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum | Hannover | |
Germany | Med.Hochschule Hannover, Kinderklinik | Hannover | |
Germany | Allergologie Jülich | Jülich | |
Germany | Allergologie Kassel | Kassel | |
Germany | HNO - Krefeld | Krefeld | |
Germany | Hals, Nasen- u. Ohrenheilkunde Lüdenscheid | Luedenscheid | |
Germany | Allgemeinmedizin Stockach, Baden | Stockach | |
Germany | Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany | Ulm | |
Germany | Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie | Wiesbaden | |
Germany | Hals, Nasen- u. Ohrenheilkunde Willich | Willich | |
Germany | Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde | Wuppertal | |
Netherlands | Meander Medisch Centrum, lokatie Baarn, Afdeling KNO | Amersfoort | |
Netherlands | Allergologen Maatschap Arnhem | Arnhem | |
Netherlands | Wilhelmina Ziekenhuis Assen, Afdeling KNO | Assen | |
Netherlands | Vlietland Ziekenhuis, lokatie Schiedam, KNO | Schiedam | |
Poland | Medical University of Bialystok, Department of Pediatrics and Allergology | Bialystok | |
Poland | Medical University of Gdansk, Department of Allergology | Gdansk | |
Poland | FARMA-MED. Sp. z o. o. | Inowroclaw | |
Poland | Jagiellonian University Medical College, Department of Allergology and Dermatology | Kraków | |
Poland | Jagiellonian University Medical College, Department of Allergy and Immunology | Kraków | |
Poland | Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi | Lodz | |
Poland | Medical University of Lodz, Department of Allergology and Pulmonology | Lodz | |
Poland | Medical University of Lodz, Department of Clinical Immunology and Allergy | Lodz | |
Poland | Medical University of Lodz, Department of Pediatrics and Allergology | Lodz | |
Poland | NZOZ Centrum Alergologii | Lodz | |
Poland | Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4 | Lublin | |
Poland | Medical University of Lublin, Department of Allergology and Immunotherapy | Lublin | |
Poland | Oddzial Dzieciecy SPZOZ | Pabianice | |
Poland | Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology | Rabka Zdrój | |
Poland | Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz | Sieradz | |
Poland | Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna | Tomaszów Mazowiecki | |
Poland | Military Institute of the Health Services, Department of Infection Disease and Allergology | Warsaw | |
Poland | Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology | Warsaw | |
Poland | Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2 | Warszawa | |
Poland | Medical University of Wroclaw, Department of Internal Disease and Allergology | Wroclaw | |
Poland | Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology | Zabrze |
Lead Sponsor | Collaborator |
---|---|
HAL Allergy |
Belgium, Germany, Netherlands, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. | June, July, August 2007 | No | |
Secondary | CIS derived variables | June, July and August 2007 | No | |
Secondary | RQLQ, quantitative skin prick test | Pollen season 2006 and 2007 | No | |
Secondary | oral allergy syndrome | October 2006 until September 2007 | No | |
Secondary | mast-cell serum tryptase | 6 months therapy | No | |
Secondary | specific immunoglobulins (IgE and IgG). | 6 months therapy | No |
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