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 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...

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.