Clinical trial NCT00422149: Twin SUBLIVAC® Grasses Clinical Efficacy Study
Official title: Twin SUBLIVAC® Grasses Clinical Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Keywords: Sublingual immunotherapy
Rhinoconjunctivitis
Lead sponsor: HAL Allergy
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
timeFrame: June, July, August 2007
Secondary outcomes:
measure: CIS derived variables
timeFrame: June, July and August 2007
measure: RQLQ, quantitative skin prick test
timeFrame: Pollen season 2006 and 2007
measure: oral allergy syndrome
timeFrame: October 2006 until September 2007
measure: mast-cell serum tryptase
timeFrame: 6 months therapy
measure: specific immunoglobulins (IgE and IgG).
timeFrame: 6 months therapy
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Dr. P. van Durme
city: Genk
country: Belgium
facility: Centrum Gespecialiseerde Geneeskunde Genk
city: Gent
country: Belgium
facility: UZ Gent, Dienst NKO, 1P1
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Afd. Allergie/Immunologie
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Dienst Kindergeneeskunde
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, lokatie St. Rafaël
city: Mechelen
country: Belgium
facility: Kinderallergie-Astma kinderz.
city: Aachen
country: Germany
facility: Allergologie Aachen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Studienzentrum Berlin
city: Braunschweig
country: Germany
facility: Allergologie Braunschweig
city: Darmstadt
country: Germany
facility: Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
city: Dorsten
country: Germany
facility: Allergologie Dorsten
city: Dortmund
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Dortmund
city: Duisburg
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Duisburg
city: Düren
country: Germany
facility: Medi-Center Düren
city: Düsseldorf
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Düsseldorf
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf, Hautklinik
city: Erlangen
country: Germany
facility: Universität Erlangen, Poliklinik für Kinder und Jugendliche
city: Essen
country: Germany
facility: Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
city: Essen
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Essen
city: Essen
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Essen
city: Gifhorn-Winkel
country: Germany
facility: Allergologie Gifhorn
city: Gütersloh
country: Germany
facility: Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
city: Hannover
country: Germany
facility: Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
city: Hannover
country: Germany
facility: Med.Hochschule Hannover, Kinderklinik
city: Jülich
country: Germany
facility: Allergologie Jülich
city: Kassel
country: Germany
facility: Allergologie Kassel
city: Krefeld
country: Germany
facility: HNO - Krefeld
city: Luedenscheid
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
city: Stockach
country: Germany
facility: Allgemeinmedizin Stockach, Baden
city: Ulm
country: Germany
facility: Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
city: Wiesbaden
country: Germany
facility: Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
city: Willich
country: Germany
facility: Hals, Nasen- u. Ohrenheilkunde Willich
city: Wuppertal
country: Germany
facility: Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
city: Arnhem
country: Netherlands
facility: Allergologen Maatschap Arnhem
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis Assen, Afdeling KNO
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis, lokatie Schiedam, KNO
city: Bialystok
country: Poland
facility: Medical University of Bialystok, Department of Pediatrics and Allergology
city: Gdansk
country: Poland
facility: Medical University of Gdansk, Department of Allergology
city: Inowroclaw
country: Poland
facility: FARMA-MED. Sp. z o. o.
city: Kraków
country: Poland
facility: Jagiellonian University Medical College, Department of Allergy and Immunology
city: Kraków
country: Poland
facility: Jagiellonian University Medical College, Department of Allergology and Dermatology
city: Lodz
country: Poland
facility: Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
city: Lodz
country: Poland
facility: NZOZ Centrum Alergologii
city: Lodz
country: Poland
facility: Medical University of Lodz, Department of Allergology and Pulmonology
city: Lodz
country: Poland
facility: Medical University of Lodz, Department of Clinical Immunology and Allergy
city: Lodz
country: Poland
facility: Medical University of Lodz, Department of Pediatrics and Allergology
city: Lublin
country: Poland
facility: Medical University of Lublin, Department of Allergology and Immunotherapy
city: Lublin
country: Poland
facility: Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
city: Pabianice
country: Poland
facility: Oddzial Dzieciecy SPZOZ
city: Rabka Zdrój
country: Poland
facility: Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
city: Sieradz
country: Poland
facility: Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
city: Tomaszów Mazowiecki
country: Poland
facility: Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
city: Warsaw
country: Poland
facility: Military Institute of the Health Services, Department of Infection Disease and Allergology
city: Warsaw
country: Poland
facility: Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
city: Warszawa
country: Poland
facility: Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
city: Wroclaw
country: Poland
facility: Medical University of Wroclaw, Department of Internal Disease and Allergology
city: Zabrze
country: Poland
facility: Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology
Study officials:
affiliation: Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany
name: R Peter, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References: