Stallergenes S.A. announces the results of a phase III clinical trial (VO55.06) conducted in China aimed at assessing the efficacy and safety of sublingual immunotherapy (Staloral(R) mites 300) in adult patients suffering from asthma triggered by house dust mites.
Study VO55.06 is a phase III randomized, double-blind, placebo-controlled study conducted over a period of 15 months in 14 centers located in China's main cities. After an observation period of 3 months, 484 adult patients with mild to moderate asthma well controlled under inhaled corticosteroid therapy were divided into two groups, one treated with Staloral(R) 300 and one given a placebo for a period of 12 months. Throughout the duration of the study, the patients received inhaled corticosteroid therapy at gradually reduced dosages. The patients were assessed on the basis of the level of asthma control as defined by GINA.
Staloral(R) 300 demonstrated statistically significant efficacy versus placebo for the control of asthma, on the basis of the following criteria: "well-controlled asthma" and "totally controlled asthma" in GINA 3 patients (moderate asthma stabilized with corticosteroids by bronchial route). In this population, the probability of a patient having his/her asthma well or totally controlled is more than twice as high with Staloral(R) 300 as it is in the placebo group (odds ratios and 95% confidence intervals of 2.10 [1.01; 4.36] and 2.43 [1.28; 4.61] respectively).
The treatment was well tolerated. There were no pulmonary side effects related to worsening of asthma or deterioration in lung function.