Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
Phase 2
Completed
- Conditions
- Allergy
- Interventions
- Biological: oral immunotherapy
- Registration Number
- NCT01191359
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- A history of Birch pollen allergy
- Positive skin prick test to birch
- Positive specific IgE to birch
Exclusion criteria:
- Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment)
- Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
- Concomitant SLIT with any allergen
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sublingual administration oral immunotherapy oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose) vestibular administration oral immunotherapy oral immunotherapy with drops applied by single dose containers (200 STU per dose)
- Primary Outcome Measures
Name Time Method Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch after 4, 8, 12, 24, 36 weeks of treatment specific antibody determination
- Secondary Outcome Measures
Name Time Method Comparison of the two administration routes with regard to safety aspects 36 weeks adverse events
Trial Locations
- Locations (1)
Universitätsklinik Bonn, Dermatology
🇩🇪Bonn, Germany