drugset / Trial / NCT01144429
Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Phase 2
Completed
344 enrolled
Leti Pharma GmbH
Labor Dr. Spranger (Central lab) · collabLaboratorios LETI SL (Study Medication) · collabPierrel Research Europe GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose. 4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. comparison between treatment arms of increased amount of quantities of allergen to provoke a positive CPT at the end of treatment.
Timeline
- Start
- 2010-06
- Primary completion
- 2011-02
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Allergoid, allergenic extract of 100% Birch | Unknown | 100 unknown | Subcutaneous |
| Comparator | Allergoid, allergenic extract of 100% Birch | Unknown | 1000 unknown | Subcutaneous |
| Comparator | Allergoid, allergenic extract of 100% Birch | Unknown | 5000 unknown | Subcutaneous |
| Comparator | Allergoid, allergenic extract of 100% Birch | Unknown | 10000 unknown | Subcutaneous |