Twin SUBLIVAC® Grasses Clinical Efficacy Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Twin SUBLIVAC® Grasses Clinical Efficacy Study

Conditions
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Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic

Intervention / Treatment
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* Drug: SUBLIVAC® Grasses/Placebo treatment
* Drug: SUBLIVAC® Grasses treatment
* Drug: Placebo treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>SUBLIVAC® Grasses treatment | Drug: SUBLIVAC® Grasses/Placebo treatment<br>* SUBLIVAC® Grasses/Placebo treatment<br>Drug: SUBLIVAC® Grasses treatment<br>* SUBLIVAC® Grasses treatment<br>|
| Placebo Comparator: 2<br>Placebo treatment | Drug: SUBLIVAC® Grasses/Placebo treatment<br>* SUBLIVAC® Grasses/Placebo treatment<br>Drug: Placebo treatment<br>* Placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sublingual immunotherapy, Rhinoconjunctivitis