Research on allergic rhinitis improvement in asthmatic children after dust mite exposure reduction: a randomized, double-blind, cross-placebo study protocol
Abstract
Background: Allergic rhinitis (AR) in children is 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, reducing the number of dust mites on mattresses and thereby potentially reducing stimulation by allergens and ultimately improving asthma and rhinitis symptoms. This single-centre, randomized, double-blind, cross-placebo trial will explore the improvement in AR in asthmatic children after dust mite exposure reduction.
Methods: We will recruit 60 children (aged 3-12 years) who have been diagnosed with AR 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 visual 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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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