Research on the improvement of allergic rhinitis in asthmatic children after reducing dust mite exposure: a randomized, double-blind, cross-placebo study protocol

Abstract

Background: Allergic rhinitis (AR) in children has become a major respiratory inflammatory disease with a high incidence that is increasing yearly. In China, 54.93% of children with asthma have AR, which often requires synchronous treatment. House dust mites (HDMs) are common allergens that often cause attacks of AR and asthma. Reducing allergen exposure is one of the most important measures to control and treat AR and asthma attacks. Hestelia Mite Bait, containing 0.1% emamectin, is a new tool for trapping and killing dust mites that can reduce the number of dust mites on mattresses, thereby may reduce stimulation by allergens and ultimately improve asthma and rhinitis symptoms. This single-centre, randomized double-blind cross-placebo trial will explore the improvement of allergic rhinitis in asthmatic children after reducing dust mite exposure.Methods: We will recruit 60 children (aged 3-12 years) who have been diagnosed with allergic rhinitis and asthma and are allergic to dust mites as confirmed by a serum allergen test. Participants will randomly receive the Hestelia Mite Bait intervention for 8 weeks and the placebo intervention for 8 weeks. There will be a 4-week washout period between the two interventions. The primary outcome is the v isual analogue scale (VAS) score of AR symptoms; the secondary outcomes include the Rhinitis Control Assessment Test (RCAT) score, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score , changes in the dust mite level, drug usage for asthma and AR , Asthma Control Questionnaire-5 (ACQ-5) score, frequency of acute asthma attacks and emergency visits, and frequency of hospitalization.Discussion: This study will scientifically and objectively evaluate the improvement effect on rhinitis and asthma after reducing dust mite exposure and provide a convenient means for the prevention and treatment of children's airway allergic diseases in the future.Trial registration : ChiCTR1900024688 (www.chictr.org.cn) registration date: July 21, 2019