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

NI-MT-08

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.

2023-11-21

2025-05-20

2025-08-20

100

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-03-20