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Twin SUBLIVAC® Grasses Clinical Efficacy Study

Primary Purpose

Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses treatment
Placebo treatment
Sponsored by
HAL Allergy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Sublingual immunotherapy, Rhinoconjunctivitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. P. van Durme
  • Centrum Gespecialiseerde Geneeskunde Genk
  • UZ Gent, Dienst NKO, 1P1
  • UZ Gasthuisberg, Afd. Allergie/Immunologie
  • UZ Gasthuisberg, Dienst Kindergeneeskunde
  • UZ Gasthuisberg, lokatie St. Rafaël
  • Kinderallergie-Astma kinderz.
  • Allergologie Aachen
  • Charité - Universitätsmedizin Berlin
  • Studienzentrum Berlin
  • Allergologie Braunschweig
  • Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
  • Allergologie Dorsten
  • Hals, Nasen- u. Ohrenheilkunde Dortmund
  • Hals, Nasen- u. Ohrenheilkunde Duisburg
  • Medi-Center Düren
  • Hals, Nasen- u. Ohrenheilkunde Düsseldorf
  • Heinrich-Heine-Universität Düsseldorf, Hautklinik
  • Universität Erlangen, Poliklinik für Kinder und Jugendliche
  • Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
  • Hals, Nasen- u. Ohrenheilkunde Essen
  • Hals, Nasen- u. Ohrenheilkunde Essen
  • Allergologie Gifhorn
  • Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
  • Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
  • Med.Hochschule Hannover, Kinderklinik
  • Allergologie Jülich
  • Allergologie Kassel
  • HNO - Krefeld
  • Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
  • Allgemeinmedizin Stockach, Baden
  • Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
  • Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
  • Hals, Nasen- u. Ohrenheilkunde Willich
  • Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
  • Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
  • Allergologen Maatschap Arnhem
  • Wilhelmina Ziekenhuis Assen, Afdeling KNO
  • Vlietland Ziekenhuis, lokatie Schiedam, KNO
  • Medical University of Bialystok, Department of Pediatrics and Allergology
  • Medical University of Gdansk, Department of Allergology
  • FARMA-MED. Sp. z o. o.
  • Jagiellonian University Medical College, Department of Allergy and Immunology
  • Jagiellonian University Medical College, Department of Allergology and Dermatology
  • Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
  • NZOZ Centrum Alergologii
  • Medical University of Lodz, Department of Allergology and Pulmonology
  • Medical University of Lodz, Department of Clinical Immunology and Allergy
  • Medical University of Lodz, Department of Pediatrics and Allergology
  • Medical University of Lublin, Department of Allergology and Immunotherapy
  • Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
  • Oddzial Dzieciecy SPZOZ
  • Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
  • Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
  • Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
  • Military Institute of the Health Services, Department of Infection Disease and Allergology
  • Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
  • Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
  • Medical University of Wroclaw, Department of Internal Disease and Allergology
  • Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

SUBLIVAC® Grasses treatment

Placebo treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CIS derived variables
RQLQ, quantitative skin prick test
oral allergy syndrome
mast-cell serum tryptase
specific immunoglobulins (IgE and IgG).

Full Information

First Posted
January 12, 2007
Last Updated
February 6, 2012
Sponsor
HAL Allergy
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1. Study Identification

Unique Protocol Identification Number
NCT00422149
Brief Title
Twin SUBLIVAC® Grasses Clinical Efficacy Study
Official Title
Twin SUBLIVAC® Grasses Clinical Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
HAL Allergy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
Keywords
Sublingual immunotherapy, Rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
SUBLIVAC® Grasses treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
SUBLIVAC® Grasses/Placebo treatment
Intervention Description
SUBLIVAC® Grasses/Placebo treatment
Intervention Type
Drug
Intervention Name(s)
SUBLIVAC® Grasses treatment
Intervention Description
SUBLIVAC® Grasses treatment
Intervention Type
Drug
Intervention Name(s)
Placebo treatment
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
Time Frame
June, July, August 2007
Secondary Outcome Measure Information:
Title
CIS derived variables
Time Frame
June, July and August 2007
Title
RQLQ, quantitative skin prick test
Time Frame
Pollen season 2006 and 2007
Title
oral allergy syndrome
Time Frame
October 2006 until September 2007
Title
mast-cell serum tryptase
Time Frame
6 months therapy
Title
specific immunoglobulins (IgE and IgG).
Time Frame
6 months therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Peter, Prof.Dr.med
Organizational Affiliation
Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. P. van Durme
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Centrum Gespecialiseerde Geneeskunde Genk
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
UZ Gent, Dienst NKO, 1P1
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gasthuisberg, Afd. Allergie/Immunologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UZ Gasthuisberg, Dienst Kindergeneeskunde
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UZ Gasthuisberg, lokatie St. Rafaël
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Kinderallergie-Astma kinderz.
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Allergologie Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Studienzentrum Berlin
City
Berlin
ZIP/Postal Code
13597
Country
Germany
Facility Name
Allergologie Braunschweig
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Allergologie Dorsten
City
Dorsten
ZIP/Postal Code
46284
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Dortmund
City
Dortmund
ZIP/Postal Code
44388
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Duisburg
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Medi-Center Düren
City
Düren
ZIP/Postal Code
52351
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Heinrich-Heine-Universität Düsseldorf, Hautklinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universität Erlangen, Poliklinik für Kinder und Jugendliche
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Essen
City
Essen
ZIP/Postal Code
45143
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Essen
City
Essen
ZIP/Postal Code
45329
Country
Germany
Facility Name
Allergologie Gifhorn
City
Gifhorn-Winkel
ZIP/Postal Code
38518
Country
Germany
Facility Name
Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
City
Gütersloh
ZIP/Postal Code
33332
Country
Germany
Facility Name
Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Med.Hochschule Hannover, Kinderklinik
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Allergologie Jülich
City
Jülich
ZIP/Postal Code
52428
Country
Germany
Facility Name
Allergologie Kassel
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
HNO - Krefeld
City
Krefeld
ZIP/Postal Code
47807
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
City
Luedenscheid
ZIP/Postal Code
58511
Country
Germany
Facility Name
Allgemeinmedizin Stockach, Baden
City
Stockach
ZIP/Postal Code
78333
Country
Germany
Facility Name
Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Hals, Nasen- u. Ohrenheilkunde Willich
City
Willich
ZIP/Postal Code
47877
Country
Germany
Facility Name
Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
City
Wuppertal
ZIP/Postal Code
42103
Country
Germany
Facility Name
Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
City
Amersfoort
ZIP/Postal Code
3800 BM
Country
Netherlands
Facility Name
Allergologen Maatschap Arnhem
City
Arnhem
ZIP/Postal Code
6224 BJ
Country
Netherlands
Facility Name
Wilhelmina Ziekenhuis Assen, Afdeling KNO
City
Assen
ZIP/Postal Code
9401RK
Country
Netherlands
Facility Name
Vlietland Ziekenhuis, lokatie Schiedam, KNO
City
Schiedam
ZIP/Postal Code
3116 BA
Country
Netherlands
Facility Name
Medical University of Bialystok, Department of Pediatrics and Allergology
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Medical University of Gdansk, Department of Allergology
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
FARMA-MED. Sp. z o. o.
City
Inowroclaw
ZIP/Postal Code
88-100
Country
Poland
Facility Name
Jagiellonian University Medical College, Department of Allergy and Immunology
City
Kraków
ZIP/Postal Code
31-066
Country
Poland
Facility Name
Jagiellonian University Medical College, Department of Allergology and Dermatology
City
Kraków
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
NZOZ Centrum Alergologii
City
Lodz
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Medical University of Lodz, Department of Allergology and Pulmonology
City
Lodz
ZIP/Postal Code
91-153
Country
Poland
Facility Name
Medical University of Lodz, Department of Clinical Immunology and Allergy
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Medical University of Lodz, Department of Pediatrics and Allergology
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Medical University of Lublin, Department of Allergology and Immunotherapy
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Oddzial Dzieciecy SPZOZ
City
Pabianice
ZIP/Postal Code
95-200
Country
Poland
Facility Name
Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
City
Rabka Zdrój
ZIP/Postal Code
34-700
Country
Poland
Facility Name
Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
City
Sieradz
ZIP/Postal Code
98-200
Country
Poland
Facility Name
Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Military Institute of the Health Services, Department of Infection Disease and Allergology
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
City
Warszawa
ZIP/Postal Code
00-521
Country
Poland
Facility Name
Medical University of Wroclaw, Department of Internal Disease and Allergology
City
Wroclaw
ZIP/Postal Code
50-417
Country
Poland
Facility Name
Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

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Twin SUBLIVAC® Grasses Clinical Efficacy Study

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