Twin SUBLIVAC® Grasses Clinical Efficacy Study

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
• Interventions: Drug: SUBLIVAC® Grasses/Placebo treatment; Drug: SUBLIVAC® Grasses treatment; Drug: Placebo treatment

• Registration Number: NCT00422149
• Lead Sponsor: HAL Allergy

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

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SUBLIVAC® Grasses/Placebo treatment	SUBLIVAC® Grasses treatment
1	SUBLIVAC® Grasses treatment	SUBLIVAC® Grasses treatment
2	SUBLIVAC® Grasses/Placebo treatment	Placebo treatment
2	Placebo treatment	Placebo treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (59)

Dr. P. van Durme; 🇧🇪 Antwerp, Belgium

Centrum Gespecialiseerde Geneeskunde Genk; 🇧🇪 Genk, Belgium

UZ Gent, Dienst NKO, 1P1; 🇧🇪 Gent, Belgium

UZ Gasthuisberg, Afd. Allergie/Immunologie; 🇧🇪 Leuven, Belgium

UZ Gasthuisberg, Dienst Kindergeneeskunde; 🇧🇪 Leuven, Belgium

UZ Gasthuisberg, lokatie St. Rafaël; 🇧🇪 Leuven, Belgium

Kinderallergie-Astma kinderz.; 🇧🇪 Mechelen, Belgium

Allergologie Aachen; 🇩🇪 Aachen, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Studienzentrum Berlin; 🇩🇪 Berlin, Germany

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