Controlled exposure to mite allergen for a dose-finding of dimethindene maleate (DMM)

Abstract

The aim of the study was to develop a laboratory system to challenge mite allergic patients with physiological concentrations of Der p I in order to evaluate the efficacy of antiallergic drugs in mite allergic patients. A double-blind, placebo-controlled, cross-over study was designed with three consecutive sessions. Twelve patients with proven sensitivity to dust mite were treated with a single dose of dimethindene maleate in a FOAD formulation (4 and 8 mg vs. placebo) 12 h before a long-term challenge with mite allergen Der p I in the Vienna challenge chamber. Challenge was performed with a constant concentration of 40 ng Der p I per cubic meter of air for 4 h. Nasal parameters were recorded at 15 min intervals during long-term challenge. In comparison to placebo, dimethindene leads to a statistically significant reduction (p < 0.05) of the nasal response at both concentrations tested. The house-dust mite model in the Vienna challenge chamber thus proved to be a useful tool for drug investigations in mite allergies.

The effect of antiallergic intranasal formulations on ciliary beat frequency of human nasal epithelium in vitro

“…DMM is a widely used H]-antagonist for oral administration or topical use on the skin. It has been reported to reduce nasal allergic symptoms significantly after systemic application (22,23), However, nothing is known about its effect on the mucociliary system so far. In our investigations, the new intranasal DMM formulation induced mild reduction of CBF, which was statistically significant when compared to the control solution and not significant when compared to the placebo formulation.…”

Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained‐release pseudoephedrine in the management of nasal congestion

“…The HDM challenge model in the VCC was first described in 1994 (16). In this study, the same HDM grains batch as for diagnostic purposes (by Allergon AB, Engelholm, Sweden) was used to provide a stable concentration (110 ng/m^) of Der p 1 throughout the challenge.…”

“…This study was a double-blind, placebo-controlled, crossover investigation to determine the efficacy and any residual effects after achievement of steady state of such a formulation when used in the relief of nasal congestion. The house-dust-mite (HDM) feces challenge in the Vienna Challenge Chamber (VCC) (16) was chosen as a suitable model for the evaluation of the efficacy of cetirizine with pseudoephedrine in these patients.…”

A direct comparison of the efficacy of antihistamines in SAR and PAR: randomised, placebo-controlled studies with levocetirizine and loratadine using an environmental exposure unit – the Vienna Challenge Chamber (VCC)

“…It is a standardised method that enables simultaneous allergen challenge of up to 20 subjects under controlled and reproducible conditions for several hours at a time. The VCC has been validated against traditional tests including: ocular challenge tests (OCT), nasal challenge tests (NCT) and the environmental challenge situation (ECS) 7,8 . Generally, comparable results are found between all tests, however, the data obtained from the VCC are more precise and reproducible as determined after several pollen and HDM allergen challenges.…”