Conjunctivitis, Allergic, Rhinitis, Allergic, Seasonal
Conditions
Keywords
Sublingual immunotherapy, Rhinoconjunctivitis
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.
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
Interventions
DRUGSUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses/Placebo treatment
DRUGSUBLIVAC® Grasses treatment
SUBLIVAC® Grasses treatment
DRUGPlacebo treatment
Placebo treatment
Sponsors
HAL Allergy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. | June, July, August 2007 |
Secondary
| Measure | Time frame |
|---|---|
| CIS derived variables | June, July and August 2007 |
| RQLQ, quantitative skin prick test | Pollen season 2006 and 2007 |
| oral allergy syndrome | October 2006 until September 2007 |
| mast-cell serum tryptase | 6 months therapy |
| specific immunoglobulins (IgE and IgG). | 6 months therapy |
Countries
Belgium, Germany, Netherlands, Poland
Outcome results
None listed