Twin SUBLIVAC® Grasses Clinical Efficacy Study

NCT00422149 | Completed Phase 3 DMC

• 2 other identifiers: SG/0021EudraCTnr: 2005-005175-16
• Study Type: interventional
• Target: 350
• Locations: 4 countries
• Sites: 60

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.

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Keywords

Sublingual immunotherapy; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.

  June, July, August 2007

Secondary Outcomes (5)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

SUBLIVAC® Grasses treatment

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

2

PLACEBO COMPARATOR

Placebo treatment

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

Interventions

SUBLIVAC® Grasses/Placebo treatment DRUG

SUBLIVAC® Grasses/Placebo treatment

1; 2

SUBLIVAC® Grasses treatment DRUG

SUBLIVAC® Grasses treatment

1

Placebo treatment DRUG

Placebo treatment

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (60)

Dr. P. van Durme

Antwerp, 2020, Belgium

Location

Centrum Gespecialiseerde Geneeskunde Genk

Genk, 3600, Belgium

Location

UZ Gent, Dienst NKO, 1P1

Ghent, 9000, Belgium

Location

UZ Gasthuisberg, Afd. Allergie/Immunologie

Leuven, 3000, Belgium

Location

UZ Gasthuisberg, Dienst Kindergeneeskunde

Leuven, 3000, Belgium

Location

UZ Gasthuisberg, lokatie St. Rafaël

Leuven, 3000, Belgium

Location

Kinderallergie-Astma kinderz.

Mechelen, 2800, Belgium

Location

Allergologie Aachen

Aachen, 52074, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Studienzentrum Berlin

Berlin, 13597, Germany

Location

Allergologie Braunschweig

Braunschweig, 38100, Germany

Location

Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie

Darmstadt, 64283, Germany

Location

Allergologie Dorsten

Dorsten, 46284, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Dortmund

Dortmund, 44388, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Duisburg

Duisburg, 47179, Germany

Location

Medi-Center Düren

Düren, 52351, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Düsseldorf

Düsseldorf, 40210, Germany

Location

Heinrich-Heine-Universität Düsseldorf, Hautklinik

Düsseldorf, 40225, Germany

Location

Universität Erlangen, Poliklinik für Kinder und Jugendliche

Erlangen, 91054, Germany

Location

Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos

Essen, 45136, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Essen

Essen, 45143, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Essen

Essen, 45329, Germany

Location

Allergologie Gifhorn

Gifhorn-Winkel, 38518, Germany

Location

Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis

Gütersloh, 33332, Germany

Location

Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum

Hanover, 30167, Germany

Location

Med.Hochschule Hannover, Kinderklinik

Hanover, 30625, Germany

Location

Allergologie Jülich

Jülich, 52428, Germany

Location

Allergologie Kassel

Kassel, 34117, Germany

Location

HNO - Krefeld

Krefeld, 47807, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Lüdenscheid

Lüdenscheid, 58511, Germany

Location

Allgemeinmedizin Stockach, Baden

Stockach, 78333, Germany

Location

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

Ulm, 89081, Germany

Location

Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie

Wiesbaden, 65183, Germany

Location

Hals, Nasen- u. Ohrenheilkunde Willich

Willich, 47877, Germany

Location

Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde

Wuppertal, 42103, Germany

Location

Meander Medisch Centrum, lokatie Baarn, Afdeling KNO

Amersfoort, 3800 BM, Netherlands

Location

Allergologen Maatschap Arnhem

Arnhem, 6224 BJ, Netherlands

Location

Wilhelmina Ziekenhuis Assen, Afdeling KNO

Assen, 9401RK, Netherlands

Location

Vlietland Ziekenhuis, lokatie Schiedam, KNO

Schiedam, 3116 BA, Netherlands

Location

Medical University of Bialystok, Department of Pediatrics and Allergology

Bialystok, 15-274, Poland

Location

Medical University of Gdansk, Department of Allergology

Gdansk, 80-211, Poland

Location

FARMA-MED. Sp. z o. o.

Inowrocław, 88-100, Poland

Location

Jagiellonian University Medical College, Department of Allergy and Immunology

Krakow, 31-066, Poland

Location

Jagiellonian University Medical College, Department of Allergology and Dermatology

Krakow, 31-531, Poland

Location

Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi

Lodz, 90-153, Poland

Location

NZOZ Centrum Alergologii

Lodz, 90-553, Poland

Location

Medical University of Lodz, Department of Allergology and Pulmonology

Lodz, 91-153, Poland

Location

Medical University of Lodz, Department of Clinical Immunology and Allergy

Lodz, 92-213, Poland

Location

Medical University of Lodz, Department of Pediatrics and Allergology

Lodz, 93-513, Poland

Location

Medical University of Lublin, Department of Allergology and Immunotherapy

Lublin, 20-093, Poland

Location

Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4

Lublin, 20-954, Poland

Location

Oddzial Dzieciecy SPZOZ

Pabianice, 95-200, Poland

Location

Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology

Rabka-Zdrój, 34-700, Poland

Location

Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz

Sieradz, 98-200, Poland

Location

Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna

Tomaszów Mazowiecki, 97-200, Poland

Location

Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2

Warsaw, 00-521, Poland

Location

Military Institute of the Health Services, Department of Infection Disease and Allergology

Warsaw, 00-909, Poland

Location

Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology

Warsaw, 00-909, Poland

Location

Medical University of Wroclaw, Department of Internal Disease and Allergology

Wroclaw, 50-417, Poland

Location

Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology

Zabrze, 41-800, Poland

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• R Peter, Prof.Dr.med

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

NL (4); BE (7); PL (21); DE (28)