Twin SUBLIVAC® Grasses Clinical Efficacy Study

• Sponsor: HAL Allergy (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00422149
• Collaborator: (none)
• Enrollment: 350
• Locations: 60
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic	Drug: SUBLIVAC® Grasses/Placebo treatment; Drug: SUBLIVAC® Grasses treatment; Drug: Placebo treatment	Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Twin SUBLIVAC® Grasses Clinical Efficacy Study
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. [June, July, August 2007]

Secondary Outcome Measures

1. CIS derived variables [June, July and August 2007]

2. RQLQ, quantitative skin prick test [Pollen season 2006 and 2007]

3. oral allergy syndrome [October 2006 until September 2007]

4. mast-cell serum tryptase [6 months therapy]

5. specific immunoglobulins (IgE and IgG). [6 months therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• HAL Allergy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00422149
• Other Study ID Numbers: SG/0021; EudraCTnr: 2005-005175-16
• First Posted: Jan 15, 2007
• Last Update Posted: Feb 7, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by , ,: Sublingual immunotherapy; Rhinoconjunctivitis
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic

Study Results

No Results Posted as of Feb 7, 2012