An observational study in Allergic Rhinitis Due to House Dust Mite and Allergic Asthma, sponsored by ALK-Abelló A/S. Enrolling by invitation at 1 site in China. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by ALK-Abelló A/S · Observational
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.
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).
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 100 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →ALK-Abelló A/S is the lead sponsor of 67 studies on the registry; 2 are open to participants now.
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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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Standardised allergen extract from house dust mites
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.
Also known as: ACARIZAX® (12-SQ HDM)
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. \[minimum: 0mm; maximum: 100mm; Higher score indicates more discomfort caused by AR\]
Time frame: 12 months
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). \[minimum: 0; maximum: 20; Higher score indicates more medication use\]
Time frame: 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). \[TCRS= Rhinitis DSS+ Rhinitis DMS; minimum: 0; maximum: 24; Higher score indicates worse rhinitis symptoms and more rhinitis medication use\]
Time frame: 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.
Time frame: up to 13 months
Change in Asthma Control Questionnaire (ACQ)
• Among patients with AR and AA, the change in Asthma Control Questionnaire (ACQ) from baseline to the 12th month of treatment (Visit 4). \[minimum: 0; maximum: 6; Higher score indicates worse asthma condition\]
Time frame: 12 months
Change in the Forced Expiratory Volume in One Second (FEV1)
• Among patients with AR and AA, the change in the Forced Expiratory Volume in One Second (FEV1) from baseline to the 12th month of treatment (Visit 4).
Time frame: 12 months
Change in the ratio of FEV1 and the Force Vital Capacity (FVC)
• Among patients with AR and AA, the change in the ratio of FEV1 and the Force Vital Capacity (FVC), that is the FEV1/FVC, from baseline to the 12th month of treatment (Visit 4).
Time frame: 12 months
Change in the force mid-expiratory flow (FEF25-75%, FEF25%, FEF50%, FEF75%) value
• Among patients with AR and AA, the change in the force mid-expiratory flow (FEF25-75%, FEF25%, FEF50%, FEF75%) value from baseline to the 12th month of treatment (Visit 4).
Time frame: 12 months
Change in the Fractional Exhaled Nitric Oxide (FeNO)
• Among patients with AR and AA, the change in the Fractional Exhaled Nitric Oxide (FeNO) from baseline to the 12th month of treatment (Visit 4).
Time frame: 12 months
Total AR / (AR with AA) -related treatment costs
To describe the total AR / (AR with AA) - related treatment costs
Time frame: 12 months in a 3-month interval.
AR / (AR with AA) -related treatment costs of each outpatient visit, emergency room visit, and hospitalization
To describe the AR / (AR with AA) - related treatment costs and break down (if applicable) of each outpatient visit, emergency room visit, and hospitalization
Time frame: 12 months in a 3-month interval
Number of outpatient visit, emergency room visit, and hospitalization due to AR / (AR with AA)
To describe the number of outpatient visit, emergency room visit, and hospitalization due to AR / (AR with AA)
Time frame: 12 months in a 3-month interval
Length of stay per hospitalization due to AR / (AR with AA)
To describe the length of stay per hospitalization due to AR / (AR with AA)
Time frame: 12 months in a 3-month interval
Plan to share: No — No sharing plan
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