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Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients

2014-08-27 03:19:30 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Allergic Rhinitis

Intervention

PURETHAL Mites 20,000 AUeq/ml, PURETHAL Mites 20,000 AUeq/ml, PURETHAL Mites 20,000 AUeq/ml

Location

Allergy & Asthma Center Westend
Berlin
Germany
D-14050

Status

Recruiting

Source

HAL Allergy

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:30-0400

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Medical and Biotech [MESH] Definitions

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