Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
Phase 2
Completed
- Conditions
- RhinitisConjunctivitisAsthma
- Registration Number
- NCT00857779
- Lead Sponsor
- ALK-Abelló A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 473
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
- Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method IgE-blocking factor start of treatment and 1 week after end of treatment
- Secondary Outcome Measures
Name Time Method Tolerability of two different updosing schedules throughout treatment
Trial Locations
- Locations (1)
Allergists' practice Dr. Kirsten Jung
🇩🇪Erfurt, Thueringen, Germany
Allergists' practice Dr. Kirsten Jung🇩🇪Erfurt, Thueringen, Germany