Study on the effectiveness of allergen immunotherapy in patients with house dust mite-induced allergic rhinitis and other associated allergic conditions
| ISRCTN | ISRCTN32263767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32263767 |
| Secondary identifying numbers | HKSH RC-2019-06 |
- Submission date
- 13/05/2019
- Registration date
- 14/05/2019
- Last edited
- 14/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Allergy Centre
Hong Kong Sanatorium & Hospital
9/F
Li Shu Pui Block
2 Village Road
Happy Valley
Hong Kong
N/A
Hong Kong
 ORCID ID |
0000-0003-1382-3690 |
|---|---|
| Phone | +85228358430 |
| awmc@hku.hk |
Study information
| Study design | Retrospective Case Control Study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effectiveness of allergen-specific sublingual immunotherapy for house dust mite-induced allergic rhinitis and its co-morbid conditions |
| Study acronym | N/A |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2019 |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | Suffering from house dust mite-induced perennial allergic rhinitis. |
| Key exclusion criteria | 1. Incomplete records of clinical data. 2. Concurrent systemic immunological disorders. 3. Using immunomodulatory treatment. |
| Date of first enrolment | 01/03/2019 |
| Date of final enrolment | 01/03/2021 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Hong Kong
N/A
Hong Kong
Sponsor information
Hospital/treatment centre
2 Village Road
Happy Valley
Hong Kong
N/A
Hong Kong
| Phone | +852 2572 0211 |
|---|---|
| hospital@hksh-hospital.com | |
| Website | www.hksh.com |
"ROR" |
https://ror.org/010mjn423 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Study results on primary, secondary and relevant outcomes will be published in a peer reviewed medical journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
14/05/2019: Trial's existence confirmed by the Hong Kong Sanatorium & Hospital Research Ethics Committee.
