Aim: The purpose of this 3-year randomised, double-blind, placebo-controlled study was to evaluate an inhaled corticosteroid (ICS)-sparing effect of specific allergy vaccination (SAV) and to assess markers of airway inflammation and skin sensitivity. Methods: Fifty-four adult patients with asthma caused by house dust mite allergy were randomized to subcutaneous SAV (Alutard SQ) or placebo injections. Asthma severity classification was based on ICS dose and GINA with moderate asthma 500-1000 μg and severe > 1000 μg fluticasone propionate/day. Results: In patients with moderate asthma (n=42) after two years of treatment the median reduction in the SAV group was 50% compared to 25% in the placebo group (p=0.01) and 90% for SAV and 42% in the placebo group after three years (p=0.04).

Figure 1. Median % reduction of ICS in moderate asthma. -·- active, -o- placebo. Including all patients (moderate and severe asthma) the reduction was statistical significant after two years of treatment (p=0.03) but not after three years. Conclusion: The clinical efficacy of SAV (with Alutard SQ) was shown by an ICS sparing effect in moderate asthma. The immunomodulatory properties of SAV were confirmed by bronchial and skin sensitivity assessments. The study shows that SAV is safe.