Twin SUBLIVAC® Grasses Clinical Efficacy Study - Full Text View

Purpose

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	Intervention	Phase
Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic	Drug: SUBLIVAC® Grasses/Placebo treatment Drug: SUBLIVAC® Grasses treatment Drug: Placebo treatment	Phase III

MedlinePlus related topics:

Allergy Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Twin SUBLIVAC® Grasses Clinical Efficacy Study

Further study details as provided by HAL Allergy:

Primary Outcome Measures:

Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. [ Time Frame: June, July, August 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CIS derived variables [ Time Frame: June, July and August 2007 ] [ Designated as safety issue: No ]
RQLQ, quantitative skin prick test [ Time Frame: Pollen season 2006 and 2007 ] [ Designated as safety issue: No ]
oral allergy syndrome [ Time Frame: October 2006 until September 2007 ] [ Designated as safety issue: No ]
mast-cell serum tryptase [ Time Frame: 6 months therapy ] [ Designated as safety issue: No ]
specific immunoglobulins (IgE and IgG). [ Time Frame: 6 months therapy ] [ Designated as safety issue: No ]

Enrollment:	350
Study Start Date:	September 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator SUBLIVAC® Grasses treatment	Drug: SUBLIVAC® Grasses/Placebo treatment SUBLIVAC® Grasses/Placebo treatment Drug: SUBLIVAC® Grasses treatment SUBLIVAC® Grasses treatment
2: Placebo Comparator Placebo treatment	Drug: SUBLIVAC® Grasses/Placebo treatment SUBLIVAC® Grasses/Placebo treatment Drug: Placebo treatment Placebo 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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422149

Show 60 Study Locations

Sponsors and Collaborators

HAL Allergy

Investigators


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

More Information

Responsible Party:	HAL Allergy BV ( H.A.J. Kleinjans )
Study ID Numbers:	SG/0021, EudraCTnr: 2005-005175-16
First Received:	January 12, 2007
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00422149
Health Authority:	Germany: Paul-Ehrlich-Institut; Netherlands: Medical Ethics Review Committee (METC); Poland: Ministry of Health; Belgium: Institutional Review Board

Keywords provided by HAL Allergy:

Sublingual immunotherapy

Rhinoconjunctivitis

Study placed in the following topic categories:

Hypersensitivity

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Conjunctivitis, Allergic

Eye Diseases

Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate

Rhinitis

Conjunctivitis

Conjunctival Diseases

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Nose Diseases

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	HAL Allergy
Information provided by:	HAL Allergy
ClinicalTrials.gov Identifier:	NCT00422149