Twin SUBLIVAC® Grasses Clinical Efficacy Study

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Twin SUBLIVAC® Grasses Clinical Efficacy Study

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

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis, Allergic, Seasonal

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