Status:
ENROLLING_BY_INVITATION
Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Allergic Rhinitis Due to House Dust Mite
Allergic Asthma
Eligibility:
All Genders
12-65 years
Brief 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 ...
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 20 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06151938
Start Date
November 21 2023
End Date
August 20 2025
Last Update
March 20 2024
Active Locations (1)
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1
Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan, China, 571400