Plain English Summary
Background and study aims
Allergen-specific sublingual immunotherapy (SLIT) is an effective disease-modifying treatment for house dust mite-induced allergic rhinitis. However, research on its effectiveness on its concomitant allergic conditions is scarce. As a response, the effectiveness of SLIT in patients with house dust mite (HDM) induced allergic rhinitis, and its concomitant allergic diseases including asthma, allergic conjunctivitis and atopic dermatitis has been evaluated in this study.
Who can participate?
Patients suffering from house dust mite-induced allergic rhinitis.
What does the study involve?
All participants’ records in the standardized questionnaire reflecting their progress including their symptoms, medication use and side effect were retrieved and reviewed. Participants were allocated to one of the two groups depending on whether they received sublingual immunotherapy in allergy centre. Participants in the study group received sublingual immunotherapy with house dust mite allergen extract daily for at least 12 months in addition to conventional treatment. Participants in the control group received conventional treatment as usual practice. Symptom scores of allergic rhinitis, asthma, allergic conjunctivitis, and eczema were assessed. The medication usage including antihistamines and nasal topical steroids were also recorded. Any treatment-related side effect during the study period was documented according to the grading system recommended by the World Allergy Organization.
What are the possible benefits and risks of participating?
Participants need to complete a standardized questionnaire each time during their follow up visits for up to 36 months during the study period. Otherwise, there is no additional risk by taking part in this study. All Participants’ record data were anonymized.
Where is the study run from?
Allergy Centre of Hong Kong Sanatorium & Hospital
When is the study starting and how long is it expected to run for?
1 March 2019 to 1 March 2021
Who is funding the study?
Allergy Centre of Hong Kong Sanatorium & Hospital
Who is the main contact?
Dr. Alson Chan
awmc@hku.hk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alson Chan
ORCID ID
http://orcid.org/0000-0003-1382-3690
Contact details
Allergy Centre
Hong Kong Sanatorium & Hospital
9/F
Li Shu Pui Block
2 Village Road
Happy Valley
Hong Kong
N/A
Hong Kong
+85228358430
awmc@hku.hk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
HKSH RC-2019-06
Study information
Scientific title
Effectiveness of allergen-specific sublingual immunotherapy for house dust mite-induced allergic rhinitis and its co-morbid conditions
Acronym
N/A
Study hypothesis
Allergen-specific sublingual immunotherapy is an effective treatment for house dust mite-induced allergic rhinitis, as well as it co-morbid allergic conditions
Ethics approval
Approved 25/02/2019, Hong Kong Sanatorium & Hospital Research Ethics Committee (Research Ethics Committee, Hong Kong Sanatorium & Hospital, 38/F, Li Shu Pui Block, 2 Village Road, Happy Valley, Hong Kong; +852 2572 0211; hospital@hksh-hospital.com), ref: RC-2019-06.
Study design
Retrospective Case Control Study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
House dust mite induced allergic diseases
Intervention
Patients diagnosed to have house dust mite-induced perennial allergic rhinitis according to ARIA guidelines who received sublingual immunotherapy (SLIT) with sublingual allergen extract for over 12 months were enrolled as case, and controls were age- and sex-matched patients with the same diagnosis who were never treated with SLIT. All enrolled patients will be followed up regularly once every 3 months and given a standardized questionnaire at every visit to record their symptom severity, medication use and treatment-related adverse events. They will be followed-up regularly until 36 months.
Intervention type
Drug
Phase
Not Applicable
Drug names
House dust mite sublingual allergen extract
Primary outcome measure
Symptom scores are measured using a standardized questionnaire at baseline and then every 3 months.
Secondary outcome measures
Medication use is measured using a standardized questionnaire at baseline and then every 3 months.
Overall trial start date
01/01/2019
Overall trial end date
01/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Suffering from house dust mite-induced perennial allergic rhinitis.
Participant type
All
Age group
All
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Incomplete records of clinical data.
2. Concurrent systemic immunological disorders.
3. Using immunomodulatory treatment.
Recruitment start date
01/03/2019
Recruitment end date
01/03/2021
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Hong Kong Sanatorium & Hospital
2 Village Road, Happy Valley, Hong Kong
Hong Kong
N/A
Hong Kong
Sponsor information
Organisation
Hong Kong Sanatorium & Hospital
Sponsor details
2 Village Road
Happy Valley
Hong Kong
N/A
Hong Kong
+852 2572 0211
hospital@hksh-hospital.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hong Kong Sanatorium & Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Study results on primary, secondary and relevant outcomes will be published in a peer reviewed medical journal.
IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/06/2020
Participant level data
Other
Basic results (scientific)
Publication list