Efficacy and tolerability of a house dust mite allergoid in allergic bronchial asthma: a randomized dose-ranging trial.

AIM: This multicenter randomized placebo-controlled double-blind clinical trial investigated which maintenance dose shows the optimal benefit-risk ratio for subcutaneous immunotherapy with a Dermatophagoides pteronyssinus allergoid preparation.

OBJECTIVE

To evaluate four maintenance doses of the allergoid preparation versus placebo.

METHODS

The late-phase reaction of the intracutaneous test was chosen as efficacy parameter and minimal dose of fluticasone required for asthma control.

RESULTS

A total of 146 adults with bronchial asthma were randomized. After subcutaneous immunotherapy, reductions in swelling size were greatest with 10,000 therapeutic units (TU). The 18,000 TU group showed the highest percentage of patients with fluticasone dose reduced to 0 μg/day.

CONCLUSION

The optimal dose of allergoid for the investigation in a confirmatory trial with inhaled corticosteroid reduction is 18,000 TU.