Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis

Launched by ALK-ABELLÓ A/S · Nov 21, 2023

Keywords

ClinConnect Summary

This is a real-world, prospective study looking at how well a daily allergy tablet called ACARIZAX® (house dust mite immunotherapy) works for people with dust-m mite–related allergic rhinitis, with or without allergic asthma, in China. About 100 participants aged 12–65 (adolescents 12–17 and adults 18–65) who have been newly prescribed ACARIZAX® will be followed for 12 months at a single center in Hainan. Participants must have dust mite allergy confirmed by testing and ongoing moderate-to-severe symptoms despite standard allergy medicines; adults with asthma should have reasonably preserved lung function, and anyone with other eligibility concerns (like severe recent asthma flares or certain medical conditions) would not be enrolled. The study is observational, so it will mainly collect information during normal care rather than test a new treatment against a placebo.

Participants can expect five study visits over about 13 months (start with the first ACARIZAX® dose, then at roughly 3, 6, 9, and 12 months). Researchers will gather data from these visits and use three symptom-and-quality-of-life tools to see how well they track changes after a year: daily symptom scores, a rhinitis quality-of-life questionnaire, and a simple neck-to-toe global discomfort scale. They’ll also track how much rescue medication is used and rhinitis-related costs, plus any adverse events or hospital visits. The main goal is to see how the three measurement tools relate to each other, while also describing safety and healthcare use in real-world use of ACARIZAX®. The study is sponsored by ALK-Abelló A/S and does not involve sharing individual patient data.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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.
• * 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.
• Exclusion Criteria:
• • 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.