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Study protocol
Research on the improvement of allergic rhinitis in asthmatic children after reducing dust mite exposure: a randomized, double-blind, cross-placebo study protocol
Ming Chen
Shanghai Jiao Tong University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9826-6971
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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
Keywords
allergic rhinitis, asthma, dust mite
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CURRENT STATUS: Published
Version 2
Posted 01 Jun, 2020
Published
On 29 Jul, 2020
No community comments so far
Editorial decision: Minor revision
On 01 Jun, 2020
Reviewer #2 agreed
On 27 May, 2020
Review #2 received
Received 27 May, 2020
Review #1 received
Received 27 May, 2020
Reviewers invited
Invitations sent on 26 May, 2020
Reviewer #1 agreed
On 26 May, 2020
Editor assigned
On 24 May, 2020
Submission checks complete
On 23 May, 2020
No comments provided
Editorial decision: Major revision
On 23 Apr, 2020
Reviewer #3 agreed
On 23 Apr, 2020
Review #2 received
Received 23 Apr, 2020
Reviewer #2 agreed
On 22 Apr, 2020
Reviewer #1 agreed
On 09 Mar, 2020
Review #1 received
Received 09 Mar, 2020
Reviewers invited
Invitations sent on 02 Mar, 2020
Editor assigned
On 29 Feb, 2020
Submission checks complete
On 25 Feb, 2020
First submitted
On 07 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Research on the improvement of allergic rhinitis in asthmatic children after reducing dust mite exposure: a randomized, double-blind, cross-placebo study protocol
Ming Chen
Shanghai Jiao Tong University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9826-6971
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 01 Jun, 2020
Published
On 29 Jul, 2020
No community comments so far
Editorial decision: Minor revision
On 01 Jun, 2020
Reviewer #2 agreed
On 27 May, 2020
Review #2 received
Received 27 May, 2020
Review #1 received
Received 27 May, 2020
Reviewers invited
Invitations sent on 26 May, 2020
Reviewer #1 agreed
On 26 May, 2020
Editor assigned
On 24 May, 2020
Submission checks complete
On 23 May, 2020
No comments provided
Editorial decision: Major revision
On 23 Apr, 2020
Reviewer #3 agreed
On 23 Apr, 2020
Review #2 received
Received 23 Apr, 2020
Reviewer #2 agreed
On 22 Apr, 2020
Reviewer #1 agreed
On 09 Mar, 2020
Review #1 received
Received 09 Mar, 2020
Reviewers invited
Invitations sent on 02 Mar, 2020
Editor assigned
On 29 Feb, 2020
Submission checks complete
On 25 Feb, 2020
First submitted
On 07 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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