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

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


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.

Study Design

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


Allergic Rhinitis


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


Allergy & Asthma Center Westend




HAL Allergy

Results (where available)

View Results


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

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Medical and Biotech [MESH] Definitions

Family of MITES in the superfamily Trombiculoidea, suborder Prostigmata, which attack humans and other vertebrates, causing DERMATITIS and severe allergic reactions. Chiggers, red bugs, and harvest mites commonly refer to the larval stage of Trombiculid mites, the only parasitic stage of the mite's life cycle.

Any arthropod of the subclass ACARI except the TICKS. They are minute animals related to the spiders, usually having transparent or semitransparent bodies. They may be parasitic on humans and domestic animals, producing various irritations of the skin (MITE INFESTATIONS). Many mite species are important to human and veterinary medicine as both parasite and vector. Mites also infest plants.

Family of spider MITES, in the superfamily Tetranychoidea, suborder Trombidiformes.

A family of MITES in the subclass ACARI. It includes the single genus Varroa.

A class of Arthropoda that includes SPIDERS; TICKS; MITES; and SCORPIONS.

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