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

NCT06151938 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-03-20

No results posted yet for this study

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 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.

Conditions

  • Allergic Rhinitis Due to House Dust Mite
  • Allergic Asthma

Interventions

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.

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Wei Tang, PhD, MD · Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2025-05-20
Completion
2025-08-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06151938 on ClinicalTrials.gov