Twin SUBLIVAC® Grasses Clinical Efficacy Study

NCT ID: NCT00422149

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-10-31

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

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

SUBLIVAC® Grasses treatment

Group Type: ACTIVE_COMPARATOR

SUBLIVAC® Grasses/Placebo treatment

Intervention Type: DRUG

SUBLIVAC® Grasses/Placebo treatment

SUBLIVAC® Grasses treatment

Intervention Type: DRUG

SUBLIVAC® Grasses treatment

2

Placebo treatment

Group Type: PLACEBO_COMPARATOR

SUBLIVAC® Grasses/Placebo treatment

Intervention Type: DRUG

SUBLIVAC® Grasses/Placebo treatment

Placebo treatment

Intervention Type: DRUG

Placebo treatment

Interventions

SUBLIVAC® Grasses/Placebo treatment

SUBLIVAC® Grasses/Placebo treatment

Intervention Type: DRUG

SUBLIVAC® Grasses treatment

SUBLIVAC® Grasses treatment

Intervention Type: DRUG

Placebo treatment

Placebo treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAL Allergy

INDUSTRY

Sponsor Role: lead

Responsible Party

HAL Allergy BV

Principal Investigators

R Peter, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany

Locations

Dr. P. van Durme

Antwerp, , Belgium

Centrum Gespecialiseerde Geneeskunde Genk

Genk, , Belgium

UZ Gent, Dienst NKO, 1P1

Ghent, , 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, , Belgium

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

Hanover, , Germany

Med.Hochschule Hannover, Kinderklinik

Hanover, , Germany

Allergologie Jülich

Jülich, , Germany

Allergologie Kassel

Kassel, , Germany

HNO - Krefeld

Krefeld, , Germany

Hals, Nasen- u. Ohrenheilkunde Lüdenscheid

Lüdenscheid, , 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, , Germany

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, , Netherlands

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.

Inowrocław, , Poland

Jagiellonian University Medical College, Department of Allergy and Immunology

Krakow, , Poland

Jagiellonian University Medical College, Department of Allergology and Dermatology

Krakow, , Poland

Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi

Lodz, , Poland

NZOZ Centrum Alergologii

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

Medical University of Lublin, Department of Allergology and Immunotherapy

Lublin, , Poland

Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4

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

Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2

Warsaw, , 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

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, , Poland

Countries

Belgium; Germany; Netherlands; Poland

Other Identifiers

EudraCTnr: 2005-005175-16

Identifier Type: -

Identifier Source: secondary_id

SG/0021

Identifier Type: -

Identifier Source: org_study_id