Twin SUBLIVAC® Grasses Clinical Efficacy Study
- Conditions
- Rhinitis, Allergic, SeasonalConjunctivitis, Allergic
- Interventions
- Drug: SUBLIVAC® Grasses/Placebo treatmentDrug: SUBLIVAC® Grasses treatmentDrug: Placebo treatment
- Registration Number
- NCT00422149
- Lead Sponsor
- HAL Allergy
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 SUBLIVAC® Grasses/Placebo treatment SUBLIVAC® Grasses treatment 1 SUBLIVAC® Grasses treatment SUBLIVAC® Grasses treatment 2 SUBLIVAC® Grasses/Placebo treatment Placebo treatment 2 Placebo treatment Placebo treatment
- Primary Outcome Measures
Name Time Method Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. June, July, August 2007
- Secondary Outcome Measures
Name Time Method CIS derived variables June, July and August 2007 RQLQ, quantitative skin prick test Pollen season 2006 and 2007 oral allergy syndrome October 2006 until September 2007 mast-cell serum tryptase 6 months therapy specific immunoglobulins (IgE and IgG). 6 months therapy
Trial Locations
- Locations (59)
Centrum Gespecialiseerde Geneeskunde Genk
🇧🇪Genk, Belgium
Allergologie Aachen
🇩🇪Aachen, Germany
Allergologie Braunschweig
🇩🇪Braunschweig, Germany
UZ Gasthuisberg, lokatie St. Rafaël
🇧🇪Leuven, Belgium
Medical University of Lublin, Department of Allergology and Immunotherapy
🇵🇱Lublin, Poland
Allergologen Maatschap Arnhem
🇳🇱Arnhem, Netherlands
Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
🇩🇪Darmstadt, Germany
Hals, Nasen- u. Ohrenheilkunde Dortmund
🇩🇪Dortmund, Germany
Allergologie Jülich
🇩🇪Jülich, Germany
Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
🇩🇪Essen, Germany
UZ Gent, Dienst NKO, 1P1
🇧🇪Gent, Belgium
UZ Gasthuisberg, Dienst Kindergeneeskunde
🇧🇪Leuven, Belgium
Wilhelmina Ziekenhuis Assen, Afdeling KNO
🇳🇱Assen, Netherlands
Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
🇩🇪Gütersloh, Germany
Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
🇩🇪Wiesbaden, Germany
Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
🇩🇪Wuppertal, Germany
Vlietland Ziekenhuis, lokatie Schiedam, KNO
🇳🇱Schiedam, Netherlands
Hals, Nasen- u. Ohrenheilkunde Willich
🇩🇪Willich, Germany
Dr. P. van Durme
🇧🇪Antwerp, Belgium
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Studienzentrum Berlin
🇩🇪Berlin, Germany
Allergologie Dorsten
🇩🇪Dorsten, Germany
Hals, Nasen- u. Ohrenheilkunde Düsseldorf
🇩🇪Düsseldorf, Germany
Medical University of Gdansk, Department of Allergology
🇵🇱Gdansk, Poland
Hals, Nasen- u. Ohrenheilkunde Duisburg
🇩🇪Duisburg, Germany
Med.Hochschule Hannover, Kinderklinik
🇩🇪Hannover, Germany
Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
🇩🇪Ulm, Germany
Medical University of Lodz, Department of Allergology and Pulmonology
🇵🇱Lodz, Poland
Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
🇵🇱Lublin, Poland
Allergologie Gifhorn
🇩🇪Gifhorn-Winkel, Germany
Universität Erlangen, Poliklinik für Kinder und Jugendliche
🇩🇪Erlangen, Germany
Hals, Nasen- u. Ohrenheilkunde Essen
🇩🇪Essen, Germany
Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
🇩🇪Hannover, Germany
Allergologie Kassel
🇩🇪Kassel, Germany
Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
🇩🇪Luedenscheid, Germany
Allgemeinmedizin Stockach, Baden
🇩🇪Stockach, Germany
Medi-Center Düren
🇩🇪Düren, Germany
Heinrich-Heine-Universität Düsseldorf, Hautklinik
🇩🇪Düsseldorf, Germany
HNO - Krefeld
🇩🇪Krefeld, Germany
Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
🇳🇱Amersfoort, Netherlands
Medical University of Bialystok, Department of Pediatrics and Allergology
🇵🇱Bialystok, Poland
FARMA-MED. Sp. z o. o.
🇵🇱Inowroclaw, Poland
Jagiellonian University Medical College, Department of Allergy and Immunology
🇵🇱Kraków, Poland
Jagiellonian University Medical College, Department of Allergology and Dermatology
🇵🇱Kraków, Poland
Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
🇵🇱Lodz, Poland
NZOZ Centrum Alergologii
🇵🇱Lodz, Poland
Medical University of Lodz, Department of Clinical Immunology and Allergy
🇵🇱Lodz, Poland
Oddzial Dzieciecy SPZOZ
🇵🇱Pabianice, Poland
Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
🇵🇱Rabka Zdrój, Poland
Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
🇵🇱Tomaszów Mazowiecki, Poland
Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
🇵🇱Warsaw, Poland
Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
🇵🇱Sieradz, Poland
Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology
🇵🇱Zabrze, Poland
Medical University of Wroclaw, Department of Internal Disease and Allergology
🇵🇱Wroclaw, Poland
Medical University of Lodz, Department of Pediatrics and Allergology
🇵🇱Lodz, Poland
UZ Gasthuisberg, Afd. Allergie/Immunologie
🇧🇪Leuven, Belgium
Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
🇵🇱Warszawa, Poland
Kinderallergie-Astma kinderz.
🇧🇪Mechelen, Belgium
Military Institute of the Health Services, Department of Infection Disease and Allergology
🇵🇱Warsaw, Poland