Twin SUBLIVAC® Grasses Clinical Efficacy Study

HAL Allergie

Status and phase

Completed

Phase 3

Conditions

Conjunctivitis, Allergic

Rhinitis, Allergic, Seasonal

Treatments

Drug: SUBLIVAC® Grasses treatment

Drug: SUBLIVAC® Grasses/Placebo treatment

Drug: Placebo treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00422149

SG/0021

EudraCTnr: 2005-005175-16

Details and patient eligibility

About

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.

Full 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

Enrollment

350 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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