Status:
COMPLETED
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Rhinitis
Conjunctivitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
- Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00857779
Start Date
February 1 2009
End Date
October 1 2009
Last Update
February 8 2013
Active Locations (1)
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1
Allergists' practice Dr. Kirsten Jung
Erfurt, Thuringia, Germany, D-99084