Twin SUBLIVAC® Grasses Clinical Efficacy Study

February 6, 2012 updated by: HAL Allergy
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Dr. P. van Durme
      • Genk, Belgium, 3600
        • Centrum Gespecialiseerde Geneeskunde Genk
      • Gent, Belgium, 9000
        • UZ Gent, Dienst NKO, 1P1
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg, Afd. Allergie/Immunologie
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg, Dienst Kindergeneeskunde
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg, lokatie St. Rafaël
      • Mechelen, Belgium, 2800
        • Kinderallergie-Astma kinderz.
  • Germany
      • Aachen, Germany, 52074
        • Allergologie Aachen
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 13597
        • Studienzentrum Berlin
      • Braunschweig, Germany, 38100
        • Allergologie Braunschweig
      • Darmstadt, Germany, 64283
        • Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
      • Dorsten, Germany, 46284
        • Allergologie Dorsten
      • Dortmund, Germany, 44388
        • Hals, Nasen- u. Ohrenheilkunde Dortmund
      • Duisburg, Germany, 47179
        • Hals, Nasen- u. Ohrenheilkunde Duisburg
      • Düren, Germany, 52351
        • Medi-Center Düren
      • Düsseldorf, Germany, 40210
        • Hals, Nasen- u. Ohrenheilkunde Düsseldorf
      • Düsseldorf, Germany, 40225
        • Heinrich-Heine-Universität Düsseldorf, Hautklinik
      • Erlangen, Germany, 91054
        • Universität Erlangen, Poliklinik für Kinder und Jugendliche
      • Essen, Germany, 45136
        • Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
      • Essen, Germany, 45143
        • Hals, Nasen- u. Ohrenheilkunde Essen
      • Essen, Germany, 45329
        • Hals, Nasen- u. Ohrenheilkunde Essen
      • Gifhorn-Winkel, Germany, 38518
        • Allergologie Gifhorn
      • Gütersloh, Germany, 33332
        • Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
      • Hannover, Germany, 30167
        • Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
      • Hannover, Germany, 30625
        • Med.Hochschule Hannover, Kinderklinik
      • Jülich, Germany, 52428
        • Allergologie Jülich
      • Kassel, Germany, 34117
        • Allergologie Kassel
      • Krefeld, Germany, 47807
        • HNO - Krefeld
      • Luedenscheid, Germany, 58511
        • Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
      • Stockach, Germany, 78333
        • Allgemeinmedizin Stockach, Baden
      • Ulm, Germany, 89081
        • Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
      • Wiesbaden, Germany, 65183
        • Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
      • Willich, Germany, 47877
        • Hals, Nasen- u. Ohrenheilkunde Willich
      • Wuppertal, Germany, 42103
        • Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
  • Netherlands
      • Amersfoort, Netherlands, 3800 BM
        • Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
      • Arnhem, Netherlands, 6224 BJ
        • Allergologen Maatschap Arnhem
      • Assen, Netherlands, 9401RK
        • Wilhelmina Ziekenhuis Assen, Afdeling KNO
      • Schiedam, Netherlands, 3116 BA
        • Vlietland Ziekenhuis, lokatie Schiedam, KNO
  • Poland
      • Bialystok, Poland, 15-274
        • Medical University of Bialystok, Department of Pediatrics and Allergology
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk, Department of Allergology
      • Inowroclaw, Poland, 88-100
        • FARMA-MED. Sp. z o. o.
      • Kraków, Poland, 31-066
        • Jagiellonian University Medical College, Department of Allergy and Immunology
      • Kraków, Poland, 31-531
        • Jagiellonian University Medical College, Department of Allergology and Dermatology
      • Lodz, Poland, 90-553
        • NZOZ Centrum Alergologii
      • Lodz, Poland, 90-153
        • Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
      • Lodz, Poland, 91-153
        • Medical University of Lodz, Department of Allergology and Pulmonology
      • Lodz, Poland, 92-213
        • Medical University of Lodz, Department of Clinical Immunology and Allergy
      • Lodz, Poland, 93-513
        • Medical University of Lodz, Department of Pediatrics and Allergology
      • Lublin, Poland, 20-093
        • Medical University of Lublin, Department of Allergology and Immunotherapy
      • Lublin, Poland, 20-954
        • Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
      • Pabianice, Poland, 95-200
        • Oddzial Dzieciecy SPZOZ
      • Rabka Zdrój, Poland, 34-700
        • Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
      • Sieradz, Poland, 98-200
        • Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
      • Tomaszów Mazowiecki, Poland, 97-200
        • Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
      • Warsaw, Poland, 00-909
        • Military Institute of the Health Services, Department of Infection Disease and Allergology
      • Warsaw, Poland, 00-909
        • Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
      • Warszawa, Poland, 00-521
        • Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
      • Wroclaw, Poland, 50-417
        • Medical University of Wroclaw, Department of Internal Disease and Allergology
      • Zabrze, Poland, 41-800
        • Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo treatment
Drug: SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses/Placebo treatment
Drug: Placebo treatment
Placebo treatment
Active Comparator: 1
SUBLIVAC® Grasses treatment
Drug: SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses/Placebo treatment
Drug: SUBLIVAC® Grasses treatment
SUBLIVAC® Grasses treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
Time Frame: June, July, August 2007
June, July, August 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
CIS derived variables
Time Frame: June, July and August 2007
June, July and August 2007
RQLQ, quantitative skin prick test
Time Frame: Pollen season 2006 and 2007
Pollen season 2006 and 2007
oral allergy syndrome
Time Frame: October 2006 until September 2007
October 2006 until September 2007
mast-cell serum tryptase
Time Frame: 6 months therapy
6 months therapy
specific immunoglobulins (IgE and IgG).
Time Frame: 6 months therapy
6 months therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HAL Allergy

Investigators

  • Principal Investigator: R Peter, Prof.Dr.med, Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 15, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG/0021
  • EudraCTnr: 2005-005175-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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