Official Title
Twin SUBLIVAC® Grasses Clinical Efficacy Study
Phase
Phase 3Lead Sponsor
HAL AllergyStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Rhinitis, Allergic, Seasonal Conjunctivitis, AllergicIntervention/Treatment
timothy grass pollen allergen extract ...Study Participants
350To 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.
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
SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses treatment
Placebo treatment
SUBLIVAC® Grasses treatment
Placebo treatment
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