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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00422149
Other study ID # SG/0021
Secondary ID EudraCTnr: 2005-
Status Completed
Phase Phase 3
First received January 12, 2007
Last updated February 6, 2012
Start date September 2006
Est. completion date October 2007

Study information

Verified date February 2012
Source HAL Allergy
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-InstitutNetherlands: Medical Ethics Review Committee (METC)Poland: Ministry of HealthBelgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses treatment
SUBLIVAC® Grasses treatment
Placebo treatment
Placebo treatment

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
HAL Allergy

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Poland, 

Outcome

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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