Allergic Rhinitis Due to House Dust MiteNCT06151938
Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
An observational study of Allergic Rhinitis Due to House Dust Mite and Allergic Asthma, run by ALK-Abelló A/S at 1 site in China.
Trial summary
The study is a single-center, observational design with a 12-month duration. Approximately 100 Chinese adult (18-65 years old) and adolescent (12-17 years old) with moderate to severe house dust mite (HDM) allergic rhinitis (AR) with or without allergic asthma (AA) who are newly prescribed ACARIZAX® will be recruited… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to House Dust Mite, Allergic Asthma
- What is being tested?
- Standardised allergen extract from house dust mites
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation [skin prick test and/or specific Immunoglobulin E (IgE)] with at least one of the following conditions: * persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication * house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.
Who may be able to join
- Adult and adolescent (12-65 years old) allergic rhinitis patients should meet each of the following criteria:
- Adult with age of 18-65 years for allergic rhinitis with or without allergic asthma. Adolescent with age of 12-17 years for allergic rhinitis.
- Clinical history and a positive test of dust mite sensitization (positive skin prick test result ≥+++ or positive specific IgE test result ≥grade 3).
- Persistent moderate to severe dust mite allergic rhinitis despite use of symptom-relieving medication (symptom assessment defined as to assess symptoms of rhinitis by VAS score≥ 5).
- Newly prescribed with ACARIZAX®.
- For adults, must provide signed informed consent; for adolescents, written informed consent must be obtained from both guardian and patient himself/herself if the level of intellectual maturity makes it appropriate.
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- Patients with allergic asthma should also meet both of the following criteria:
- Dust mite induced asthma not well controlled by inhaled corticosteroids and associated with mild to severe dust mite allergic rhinitis.
- FEV1 ≥ 70% of predicted value after adequate pharmacologic treatment.
Who cannot join
- Patients with hypersensitivity to any of the excipients.
- Patients with severe asthma exacerbations within the last 3 months.
- Asthmatic patients experiencing an acute respiratory tract infection should have the treatment postponed.
- Patients with acute severe oral inflammation and oral wounds.
- Patients who have previous treatment with Omalizumab within the last 120 days.
- Patient who currently participates in or plan to participate in any interventional clinical study.
- Any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan, 571400
About this study
Official title: A Prospective Observational Study Evaluating Relevance of Measurement Instruments in Assessing Effectiveness of ACARIZAX® in the Treatment of Moderate to Severe House Dust Mite Allergic Rhinitis With/Without Allergic Asthma in Chinese
The study is a single-center, observational design with a 12-month duration. Approximately 100 Chinese adult (18-65 years old) and adolescent (12-17 years old) with moderate to severe house dust mite (HDM) allergic rhinitis (AR) with or without allergic asthma (AA) who are newly prescribed ACARIZAX® will be recruited for evaluation of the relevance of measurement instruments. The instruments referred to three patient-report scales of allergic rhinitis symptom and quality-of-life including the Daily symptom score (DSS), Standardised rhinoconjunctivitis quality-of-life questionnaire [RQLQ(S)], and Visual analogue scale (VAS). Other data will be collected to evaluate the effectiveness and safety of ACARIZAX® under real-world clinical practices.
Read the detailed description
This is a prospective, non-interventional, observational, single-centre, open-label study. Chinese adult (18-65 years old) and adolescent (12-17 years old) HDM AR patients who are newly prescribed with ACARIZAX® at the discretion of attending physician, according to the approved indication by Hainan Provincial Health Commission, will be recruited for this study. Approximately 100 adult (18-65 years old) and adolescent (12-17 years old) patients are expected to be enrolled from Hainan Branch Hospital of Ruijin Hospital. Patients are included in the study only after the decision for treatment with ACARIZAX® has been made, and only with the objective of collecting relevant data about clinical effectiveness and safety of treatment with ACARIZAX® under real-world conditions. No further medical procedures beyond standard care at the discretion of the attending physician are necessary for participation in this study.
Over the 13-month study (including 12-month of treatment), total of 5 scheduled visits will be documented: enrolment and first administration of ACARIZAX® (Visit 1, V0), and subsequent visits performed in 3-month intervals after the first administration at the third month (Visit 2, V1), sixth month (Visit 3, V2), ninth month (Visit 4, V3), and twelfth month (Visit 5, V4) respectively. The actual number and duration of follow-up visits are according to routine practice and may be changed at the physician's discretion. All adverse events (AE) will be collected from the first dose administration until 30 days after the last dose of ACARIZAX® (end of study).
- Being tested
- Standardised allergen extract from house dust mites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised allergen extract from house dust mitesDrug
Also called ACARIZAX® (12-SQ HDM)
Drug: Allergen immunotherapy [ACARIZAX® (12-SQ HDM) house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet] for moderate to severe house dust mite allergic rhinitis with or without allergic asthma for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Standardised allergen extract from house dust mites (ACARIZAX®) | Observational study to collect real-world data: patients will be treated with ACARIZAX house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for one tablet per day. Receives: Drug: Standardised allergen extract from house dust mites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between three measurement instruments
- The correlation between the score changes from baseline to 12 months of treatment (Visit 4) of three measurement instruments (as follows).
Measurement instruments include:
- Daily symptom score (DSS) for 7 consecutive days [minimum: 0; maximum: 18; Higher score indicates worse symptoms ]
- Standardised Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)] score, [minimum: 0; maximum: 168; Higher score indicates worse quality of life]
- Visual Analog Scale (VAS) value of the global discomfort caused by AR. [minimum: 0mm; maximum: 100mm; Higher score indicates more discomfort caused by AR]
Measured: 12 months
Secondary outcomes (3)
Change in average of Daily Medication Score (DMS)
- The change in average of Daily Medication Score (DMS) for 7 consecutive days from baseline to 12th month of treatment (Visit 4).
[minimum: 0; maximum: 20; Higher score indicates more medication use]
Measured: 12 months
Change in average of Total Combined Rhinitis Score (TCRS)
- The change in average of Total Combined Rhinitis Score (TCRS) for 7 consecutive days from baseline to 12th month of treatment (Visit 4).
[TCRS= Rhinitis DSS+ Rhinitis DMS; minimum: 0; maximum: 24; Higher score indicates worse rhinitis symptoms and more rhinitis medication use]
Measured: 12 months
To describe all adverse events (AE) and serious adverse events (SAE)
- All AEs and SAEs from the study initiation to the end of study.
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start21 Nov 2023
- Primary completion20 May 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to House Dust MiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Tang, PhD, MD, Principal investigator, Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151938
- Sponsor's protocol ID
- NI-MT-08
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating Relevance of Measurement Instruments in Assessing Effectiveness of ACARIZAX® in the Treatment of Moderate to Severe House Dust Mite Allergic Rhinitis With/Without Allergic Asthma in Chinese
- ClinicalTrials.gov ID
- NCT06151938
- Acronym / sponsor ID
- NI-MT-08
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-center, observational design with a 12-month duration. Approximately 100 Chinese adult (18-65 years old) and adolescent (12-17 years old) with moderate to severe house dust mite (HDM) allergic rhinitis (AR) with or without allergic asthma (AA) who are newly prescribed ACARIZAX® will be recruited for evaluation of the relevance of measurement instruments. The instruments referred to three patient-report scales of allergic rhinitis symptom and quality-of-life including the Daily symptom score (DSS), Standardised rhinoconjunctivitis quality-of-life questionnaire [RQLQ(S)], and Visual analogue scale (VAS). Other data will be collected to evaluate the effectiveness and safety of ACARIZAX® under real-world clinical practices.
Detailed description
This is a prospective, non-interventional, observational, single-centre, open-label study. Chinese adult (18-65 years old) and adolescent (12-17 years old) HDM AR patients who are newly prescribed with ACARIZAX® at the discretion of attending physician, according to the approved indication by Hainan Provincial Health Commission, will be recruited for this study. Approximately 100 adult (18-65 years old) and adolescent (12-17 years old) patients are expected to be enrolled from Hainan Branch Hospital of Ruijin Hospital. Patients are included in the study only after the decision for treatment with ACARIZAX® has been made, and only with the objective of collecting relevant data about clinical effectiveness and safety of treatment with ACARIZAX® under real-world conditions. No further medical procedures beyond standard care at the discretion of the attending physician are necessary for participation in this study.
Over the 13-month study (including 12-month of treatment), total of 5 scheduled visits will be documented: enrolment and first administration of ACARIZAX® (Visit 1, V0), and subsequent visits performed in 3-month intervals after the first administration at the third month (Visit 2, V1), sixth month (Visit 3, V2), ninth month (Visit 4, V3), and twelfth month (Visit 5, V4) respectively. The actual number and duration of follow-up visits are according to routine practice and may be changed at the physician's discretion. All adverse events (AE) will be collected from the first dose administration until 30 days after the last dose of ACARIZAX® (end of study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardised allergen extract from house dust mites (ACARIZAX®) | – | Drug: Standardised allergen extract from house dust mitesObservational study to collect real-world data: patients will be treated with ACARIZAX house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for one tablet per day. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation [skin prick test and/or specific Immunoglobulin E (IgE)] with at least one of the following conditions: * persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication * house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.
Key inclusion criteria (9 listed)
- Adult and adolescent (12-65 years old) allergic rhinitis patients should meet each of the following criteria:
- Patients with allergic asthma should also meet both of the following criteria:
Key exclusion criteria (7 listed)
- Patients with hypersensitivity to any of the excipients.
- Patients with severe asthma exacerbations within the last 3 months.
- Asthmatic patients experiencing an acute respiratory tract infection should have the treatment postponed.
- Patients with acute severe oral inflammation and oral wounds.
- Patients who have previous treatment with Omalizumab within the last 120 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised allergen extract from house dust mitesAlso: ACARIZAX® (12-SQ HDM)Drug: Allergen immunotherapy [ACARIZAX® (12-SQ HDM) house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet] for moderate to severe house dust mite allergic rhinitis with or without allergic asthma for 12 months. | Drug | Standardised allergen extract from house dust mites (ACARIZAX®) |
Primary outcome
Correlation between three measurement instruments
Time frame: 12 months
• The correlation between the score changes from baseline to 12 months of treatment (Visit 4) of three measurement instruments (as follows). Measurement instruments include: * Daily symptom score (DSS) for 7 consecutive days [minimum: 0; maximum: 18; Higher score indicates worse symptoms ] * Standardised Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)] score, [minimum: 0; maximum: 168; Higher score indicates worse quality of life] * Visual Analog Scale (VAS) value of the global discomfort caused by AR. [minimum: 0mm; maximum: 100mm; Higher score indicates more discomfort caused by AR]
3 secondary outcomes
Change in average of Daily Medication Score (DMS)
Time frame: 12 months
Change in average of Total Combined Rhinitis Score (TCRS)
Time frame: 12 months
To describe all adverse events (AE) and serious adverse events (SAE)
Time frame: up to 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No. No sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Tang, PhD, MD principal investigator
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis Due to House Dust Mite and Allergic Asthma, run by ALK-Abelló A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between three measurement instruments (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.