EUCTR2006-005911-82-PL
Active, not recruiting
Phase 1
A multicenter, randomised, controlled, double-blind study to evaluate efficacy and safety of a perennial sublingual specific immunotherapy with a solution of grass pollen allergen extract in children with clinically relevant grass pollen sensitivity in comparison to a symptomatic standard treatment with add on placebo
Allergopharma Joachim Ganzer KG0 sites230 target enrollmentFebruary 24, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- IgE-mediated allergic disease manifested as symptoms of allergic rhinitis/rhinoconjunctivitis with or without allergic bronchial asthma (GINA I and II), triggered by grass pollen allergens.
- Sponsor
- Allergopharma Joachim Ganzer KG
- Enrollment
- 230
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female outpatients
- •Age 4 – \< 12 years
- •IgE\-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma
- •bronchiale (GINA stage I or II), attributable to grass pollen allergens, documented
- •?positive skin prick test weal for grass pollen at least as large as
- •histaminedihydrochloride (1 %) control reaction or \> 5 mm in diameter and
- •?positive RAST/CAP \> 2 to grass pollens and
- •?proven clinical relevance of grass pollen allergy by positive conjunctival
- •provocation testing with grass pollen allergens
- •For female patients with childbearing potential: Negative pregnancy test and
Exclusion Criteria
- •Previous or other current specific immunotherapy with grass pollen allergens in any
- •formulation
- •Symptoms related to or strong skin test positivity to other seasonal or perennial
- •allergens (skin prick test weal \> 5 mm and/or as large as histaminedihydrochloride
- •(1%) control reaction, if clinical relevance cannot be excluded), which are effective
- •in the same period as the relevant grass pollens (June – August)
- •Previous course of hyposensitisation against grass pollen or other allergens that
- •are not known
- •Specific immunotherapy with any other allergens during the course of the study
- •Patients that have undergone an unsuccessful course of specific immunotherapy
Outcomes
Primary Outcomes
Not specified
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