Rhinitis, Allergic, SeasonalPhase 3NCT00422149
Twin SUBLIVAC® Grasses Clinical Efficacy Study
A Phase 3 study testing SUBLIVAC® Grasses treatment in people with Rhinitis, Allergic, Seasonal and Conjunctivitis, Allergic, run by HAL Allergy at 60 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
- What is being tested?
- SUBLIVAC® Grasses treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 60 sitesin 4 countries
- Study dates
- Sep 2006to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
60 sites in 4 countries.
60 sites in 4 countries
Germany28 sites
Allergologie Aachen
Aachen, 52074
Charité - Universitätsmedizin Berlin
Berlin, 10117
Studienzentrum Berlin
Berlin, 13597
Allergologie Braunschweig
Braunschweig, 38100
Priv.-Doz. Hals-Nasen-Ohrenheilkunde plastische Operationen Allergologie
Darmstadt, 64283
Allergologie Dorsten
Dorsten, 46284
Hals, Nasen- u. Ohrenheilkunde Dortmund
Dortmund, 44388
Hals, Nasen- u. Ohrenheilkunde Duisburg
Duisburg, 47179
Medi-Center Düren
Düren, 52351
Hals, Nasen- u. Ohrenheilkunde Düsseldorf
Düsseldorf, 40210
Heinrich-Heine-Universität Düsseldorf, Hautklinik
Düsseldorf, 40225
Universität Erlangen, Poliklinik für Kinder und Jugendliche
Erlangen, 91054
Gemeinschaftspraxis Dr. M. Feldmann und Dr. N. Karadiakos
Essen, 45136
Hals, Nasen- u. Ohrenheilkunde Essen
Essen, 45143
Hals, Nasen- u. Ohrenheilkunde Essen
Essen, 45329
Allergologie Gifhorn
Gifhorn-Winkel, 38518
Drobnitzky Franz-Josef Dr.med. Kinderarzt-Allergologie und Frank-Peter Dr.med. Kinderarzt-Neonatologie Gemeinschaftspraxis
Gütersloh, 33332
Klinik für Pneumologie, Intensiv- und Schlafmedizin Klinikum
Hanover, 30167
Med.Hochschule Hannover, Kinderklinik
Hanover, 30625
Allergologie Jülich
Jülich, 52428
Allergologie Kassel
Kassel, 34117
HNO - Krefeld
Krefeld, 47807
Hals, Nasen- u. Ohrenheilkunde Lüdenscheid
Lüdenscheid, 58511
Allgemeinmedizin Stockach, Baden
Stockach, 78333
Zentrum für Klinische Forschung, Helmholtzstrasse 8/1, 89081 Ulm, Germany
Ulm, 89081
Gemeinschaftspraxis für HNO Heilkunde, Allergologie und plastische Chirurgie
Wiesbaden, 65183
Hals, Nasen- u. Ohrenheilkunde Willich
Willich, 47877
Gemeinschaftspraxis für Hals-Nasen-Ohrenheilkunde
Wuppertal, 42103
Poland21 sites
Medical University of Bialystok, Department of Pediatrics and Allergology
Bialystok, 15-274
Medical University of Gdansk, Department of Allergology
Gdansk, 80-211
FARMA-MED. Sp. z o. o.
Inowrocław, 88-100
Jagiellonian University Medical College, Department of Allergy and Immunology
Krakow, 31-066
Jagiellonian University Medical College, Department of Allergology and Dermatology
Krakow, 31-531
Klinika Pneumonologii i Alergologii Uniwersytet Medyczny w Lodzi
Lodz, 90-153
NZOZ Centrum Alergologii
Lodz, 90-553
Medical University of Lodz, Department of Allergology and Pulmonology
Lodz, 91-153
Medical University of Lodz, Department of Clinical Immunology and Allergy
Lodz, 92-213
Medical University of Lodz, Department of Pediatrics and Allergology
Lodz, 93-513
Medical University of Lublin, Department of Allergology and Immunotherapy
Lublin, 20-093
Klinika Pneumonologii Onkologii i Alergologii SPSK Nr 4
Lublin, 20-954
Oddzial Dzieciecy SPZOZ
Pabianice, 95-200
Institute of Allergy and Lung Disease Rabka, Department of Allergology and Pneumonology
Rabka-Zdrój, 34-700
Specjalistyczny Zespól Diagnostyczno-Konsultacyjny Problemów Alergii Emil Florkiewicz
Sieradz, 98-200
Gabinet Lekarski Bozena Kubicka-Kozik Poradnia Alergologiczna
Tomaszów Mazowiecki, 97-200
Specjalistyczny Niepubliczny Zaklad Leczenia Alergii i Diagnostyki Alergologicznej IRMED 2
Warsaw, 00-521
Military Institute of the Health Services, Department of Infection Disease and Allergology
Warsaw, 00-909
Military Institute of the Health Services, Department of Internal Disease Pulmonology and Allergology
Warsaw, 00-909
Medical University of Wroclaw, Department of Internal Disease and Allergology
Wroclaw, 50-417
Medical University of Silesia, Department of Internal Disease, Allergology and Clinical Immunology
Zabrze, 41-800
Belgium7 sites
Dr. P. van Durme
Antwerp, 2020
Centrum Gespecialiseerde Geneeskunde Genk
Genk, 3600
UZ Gent, Dienst NKO, 1P1
Ghent, 9000
UZ Gasthuisberg, Afd. Allergie/Immunologie
Leuven, 3000
UZ Gasthuisberg, Dienst Kindergeneeskunde
Leuven, 3000
UZ Gasthuisberg, lokatie St. Rafaël
Leuven, 3000
Kinderallergie-Astma kinderz.
Mechelen, 2800
Netherlands4 sites
Meander Medisch Centrum, lokatie Baarn, Afdeling KNO
Amersfoort, 3800 BM
Allergologen Maatschap Arnhem
Arnhem, 6224 BJ
Wilhelmina Ziekenhuis Assen, Afdeling KNO
Assen, 9401RK
Vlietland Ziekenhuis, lokatie Schiedam, KNO
Schiedam, 3116 BA
About this study
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.
Read the 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
- Being tested
- SUBLIVAC® Grasses/Placebo treatment, SUBLIVAC® Grasses treatment, Placebo treatment
- Keywords
- Sublingual immunotherapy, Rhinoconjunctivitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBLIVAC® Grasses/Placebo treatmentDrug
SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses treatmentDrug
SUBLIVAC® Grasses treatment
Placebo treatmentDrug
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | SUBLIVAC® Grasses treatment Receives: Drug: SUBLIVAC® Grasses/Placebo treatment; Drug: SUBLIVAC® Grasses treatment |
| 2 | Placebo comparator | Placebo treatment Receives: Drug: SUBLIVAC® Grasses/Placebo treatment; Drug: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
Measured: June, July, August 2007
Secondary outcomes (5)
CIS derived variables
Measured: June, July and August 2007
RQLQ, quantitative skin prick test
Measured: Pollen season 2006 and 2007
oral allergy syndrome
Measured: October 2006 until September 2007
mast-cell serum tryptase
Measured: 6 months therapy
specific immunoglobulins (IgE and IgG).
Measured: 6 months therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R Peter, Prof.Dr.med, Principal investigator, Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422149
- Sponsor's protocol ID
- SG/0021
- Other IDs
- EudraCTnr: 2005-005175-16
- Status last verified
- Feb 2012
- First submitted
- 12 Jan 2007
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twin SUBLIVAC® Grasses Clinical Efficacy Study
- ClinicalTrials.gov ID
- NCT00422149
- Acronym / sponsor ID
- SG/0021
- Keywords
- Sublingual immunotherapy, Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SUBLIVAC® Grasses/Placebo treatment, Drug: SUBLIVAC® Grasses treatmentSUBLIVAC® Grasses treatment |
| 2 | Placebo comparator | Drug: SUBLIVAC® Grasses/Placebo treatment, Drug: Placebo treatmentPlacebo treatment |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUBLIVAC® Grasses/Placebo treatmentSUBLIVAC® Grasses/Placebo treatment | Drug | 1, 2 |
| SUBLIVAC® Grasses treatmentSUBLIVAC® Grasses treatment | Drug | 1 |
| Placebo treatmentPlacebo treatment | Drug | 2 |
Primary outcome
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
Time frame: June, July, August 2007
5 secondary outcomes
CIS derived variables
Time frame: June, July and August 2007
RQLQ, quantitative skin prick test
Time frame: Pollen season 2006 and 2007
oral allergy syndrome
Time frame: October 2006 until September 2007
mast-cell serum tryptase
Time frame: 6 months therapy
specific immunoglobulins (IgE and IgG).
Time frame: 6 months therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Peter, Prof.Dr.med principal investigator
Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany
60 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SUBLIVAC® Grasses treatment in people with Rhinitis, Allergic, Seasonal and Conjunctivitis, Allergic, run by HAL Allergy at 60 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Germany, Poland, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. (time frame: June, July, August 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.