Status:
COMPLETED
Twin SUBLIVAC® Grasses Clinical Efficacy Study
Lead Sponsor:
HAL Allergy
Conditions:
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 a...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00422149
Start Date
September 1 2006
End Date
October 1 2007
Last Update
February 7 2012
Active Locations (60)
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1
Dr. P. van Durme
Antwerp, Belgium, 2020
2
Centrum Gespecialiseerde Geneeskunde Genk
Genk, Belgium, 3600
3
UZ Gent, Dienst NKO, 1P1
Ghent, Belgium, 9000
4
UZ Gasthuisberg, Afd. Allergie/Immunologie
Leuven, Belgium, 3000