Abstract
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. To evaluate four maintenance doses of the allergoid preparation versus placebo. The late-phase reaction of the intracutaneous test was chosen as efficacy parameter and minimal dose of fluticasone required for asthma control. A total of 146 adults with bronchial asthma were randomized. After subcutaneous immunotherapy, reductions in swelling size were greatest with 10,000therapeutic units (TU). The 18,000TU group showed the highest percentage of patients with fluticasone dose reduced to 0μg/day. The optimal dose of allergoid for the investigation in a confirmatory trial with inhaled corticosteroid reduction is 18,000TU.
Highlights
The primary end point for efficacy was the change in late-phase response measured 6 h after intracutaneous injection of allergen assessed at baseline and after Subcutaneous allergen immunotherapy (SCIT)
Major secondary end point was the change of the minimal inhaled corticosteroid dose necessary for asthma control assessed at baseline and after SCIT
The highest dose shows the best efficacy for the inhaled corticosteroid reduction and most other end points compared with lower doses
Summary
To evaluate the efficacy and safety of four different maintenance doses (2000, 6000, 10,000 and 18,000 TU) of D. pteronyssinus allergoid preparation In addition to measuring of the wheal size after ICT, efficacy was assessed by investigating the effects of SCIT on asthma control (using the Asthma Control Test [ACT]), lung function (morning PEF) and the serum concentrations of antibodies (IgE, IgG and IgG4 specific to HDMs using ImmunoCAP [ThermoFisher Scientific, Uppsala, Sweden]) at screening and after SCIT. Each dose-step lasted for 6 weeks until uncontrolled conditions were reached and patients with controlled asthma without fluticasone were excluded from the ACT analyses. Secondary end points were changes in the following variables from baseline to after SCIT: swelling area and volume 20 min (early-phase reaction [EPR]) after ICT; minimal ICS dose for asthma control; ACT score; morning PEF; concentrations of IgE, IgG, and IgG4 specific to D. pteronyssinus and D. farinae.
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