drugset / Trial / NCT01438463
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety. For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-05
- Completion
- 2013-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PURETHAL Mites | Unknown | 6667 unknown | Subcutaneous |
| Subject | PURETHAL Mites | Unknown | 20000 unknown | Subcutaneous |
| Subject | PURETHAL Mites | Unknown | 50000 unknown | Subcutaneous |
| Subject | PURETHAL Mites | Unknown | 100000 unknown | Subcutaneous |