IgE mediated allergic disorders triggered by grass pollen
Conditions
Interventions
Product Name: SUBLIVAC® Grasses
Pharmaceutical Form: Oromucosal drops
Other descriptive name: Grass pollen extract
Concentration type: equal
Concentration number: 10000 AU/ml-
Pharmaceutical form of t
Sponsors
HAL Allergy BV
Eligibility
Sex/Gender
All
Inclusion 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 previous years) A positive skin prick test (>3 mm) and specific serum IgE-test (>1 U/ml) for grass (Lolium perenne, Phleum pratense and Poa pratensis). Age 12 years or older. Subjects shall give a written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A positive SPT for perennial allergens of house dust mite and moulds 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, including corticosteroids (systemic and local) outside tree and 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 Pregnancy, lactation or inadequate contraceptive measures Alcohol- or drug abuse Lack of co-operation or severe psychological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To generate data with regard to safety of the product via the reported adverse events, blood safety laboratorium values and ECG's.;Primary end point(s): Difference in the mean clinical index score (CIS) measured during the pollen season between the treatment group and the control group. | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed