Research on the improvement of allergic rhinitis in asthmatic children after reducing dust mite exposure: a randomized, double-blind, cross-placebo study protocol
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 potentially reducing stimulation by allergens and ultimately improving asthma and rhinitis symptoms. This single-centre, randomized double-blind crossa-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 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, Asthma Control Questionnaire-5 (ACQ-5) score, and frequencies of acute asthma attacks, emergency visits, and hospitalization.
Discussion: This study will scientifically and objectively evaluate the improvement effects on rhinitis and asthma after reducing dust mite exposure and will 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
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Posted 01 Jun, 2020
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On 29 Feb, 2020
On 25 Feb, 2020
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Research on the improvement of allergic rhinitis in asthmatic children after reducing dust mite exposure: a randomized, double-blind, cross-placebo study protocol
Posted 01 Jun, 2020
On 29 Jul, 2020
On 01 Jun, 2020
On 27 May, 2020
Received 27 May, 2020
Received 27 May, 2020
Invitations sent on 26 May, 2020
On 26 May, 2020
On 24 May, 2020
On 23 May, 2020
On 23 Apr, 2020
On 23 Apr, 2020
Received 23 Apr, 2020
On 22 Apr, 2020
On 09 Mar, 2020
Received 09 Mar, 2020
Invitations sent on 02 Mar, 2020
On 29 Feb, 2020
On 25 Feb, 2020
On 07 Feb, 2020
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 potentially reducing stimulation by allergens and ultimately improving asthma and rhinitis symptoms. This single-centre, randomized double-blind crossa-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 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, Asthma Control Questionnaire-5 (ACQ-5) score, and frequencies of acute asthma attacks, emergency visits, and hospitalization.
Discussion: This study will scientifically and objectively evaluate the improvement effects on rhinitis and asthma after reducing dust mite exposure and will 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
Figure 1