Allergic Rhinitis Clinical Trial
Official title:
Dose Tolerability Study With High Dose PURETHAL Mites in Allergic Rhinitis / Rhinoconjunctivitis Patients
The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.
The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be determined by means of the Clinical index score (CIS) and two surrogate efficacy markers; the conjunctival provocation test (CPT) and serum levels of allergen specific immunoglobulins (IgG and IgE). These efficacy parameters are purely indicative and not decisive for the further clinical development of PURETHAL Mites. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05080322 -
Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis
|
Phase 4 | |
| Recruiting |
NCT06028490 -
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
|
Phase 2 | |
| Completed |
NCT04388358 -
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
|
N/A | |
| Recruiting |
NCT04202263 -
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
|
Phase 2 | |
| Completed |
NCT04078009 -
Standardising Nasal Allergen Challenge in Adult With Hay Fever
|
N/A | |
| Completed |
NCT03644680 -
Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study
|
N/A | |
| Completed |
NCT04541004 -
Adolescent Mite Allergy Safety Evaluation
|
Phase 3 | |
| Recruiting |
NCT05378594 -
HDM and Silver Birch NAC Standardisation
|
N/A | |
| Not yet recruiting |
NCT05684380 -
Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
|
Phase 3 | |
| Completed |
NCT02943720 -
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
|
Phase 2 | |
| Not yet recruiting |
NCT01014325 -
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
|
Phase 3 | |
| Completed |
NCT02910401 -
Clinical Response to Rhinovirus Challenge
|
Phase 2 | |
| Completed |
NCT02556801 -
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
|
Phase 2 | |
| Not yet recruiting |
NCT02233426 -
Effect of Hypertonic Solutions on Allergic Rhinitis Patients
|
N/A | |
| Completed |
NCT02352168 -
Airway Inflammation in Children With Allergic Rhinitis and Intervention
|
N/A | |
| Completed |
NCT01918956 -
PURETHAL Birch RUSH Study
|
Phase 4 | |
| Completed |
NCT01946035 -
Alpha-Blockers in Allergic Rhinitis (MAN 01)
|
Phase 4 | |
| Completed |
NCT01682070 -
SUBLIVAC FIX Phleum Pratense DT/DRF
|
Phase 2 | |
| Recruiting |
NCT01454492 -
The Relationship Between Allergic Rhinitis and Geographic Tongue
|
N/A | |
| Completed |
NCT01438463 -
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
|
Phase 2 |