To investigate whether sublingual immunotherapy (SLIT) in children and adolescents with house mite-induced allergic rhinitis is effective and safe.
Randomised, double-blind, placebo-controlled trial.
Children aged 6-18 years (n = 251) recruited in primary care with a house dust mite-induced allergic rhinitis received either SLIT or placebo for 2 years. Symptoms, medication use and adverse events were assessed throughout the study. The primary outcome parameter was the mean total nose symptom score (scales 0-12) during the fall after a 2-year treatment.
The mean nose symptom score after 2 years of treatment showed no difference between SLIT and placebo. The mean score in the SLIT group was 2.26 (SD: 1.84) versus 2.02 in the placebo group (SD: 1.67; p = 0.08). There were no statistically significant differences in secondary outcome measures, or in subgroup analyses. The number of reported adverse events was comparable between both groups.
Sublingual immunotherapy with the house-dust mite allergen was not more effective than placebo in children with allergic rhinitis in primary care. The treatment is considered to be safe.
Conflict of interest/financial support: this study was sponsored by Artu Biologicals.