Asthma, Conjunctivitis, Rhinitis
Conditions
Keywords
allergen immunotherapy, allergy to grass pollen
Brief summary
The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ
Interventions
BIOLOGICALsubcutaneous immunotherapy
7 injections
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season * Lack of adequate relief with symptomatic medication during the previous grass pollen season * Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter \>= 3mm) currently performed or not older than 60 days before screening
Exclusion criteria
* FEV1 \< 70% of predicted value at screening * Bronchial asthma corresponding to GINA step 3 or more, even if controlled * History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months * Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgE-blocking factor | start of treatment and 1 week after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability of two different updosing schedules | throughout treatment |
Countries
Germany
Outcome results
None listed