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

NCT06151938 | Enrolling By Invitation

• 1 other identifier: NI-MT-08
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 (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

Outcome Measures

Primary Outcomes (1)

• Correlation between three measurement instruments

  • The correlation between the score changes from baseline to 12 months of treatment (Visit 4) of three measurement instruments (as follows). Measurement instruments include: * Daily symptom score (DSS) for 7 consecutive days \[minimum: 0; maximum: 18; Higher score indicates worse symptoms \] * Standardised Rhinoconjunctivitis Quality of Life Questionnaire \[RQLQ(S)\] score, \[minimum: 0; maximum: 168; Higher score indicates worse quality of life\] * Visual Analog Scale (VAS) value of the global discomfort caused by AR. \[minimum: 0mm; maximum: 100mm; Higher score indicates more discomfort caused by AR\]

  12 months

Secondary Outcomes (3)

• Change in average of Daily Medication Score (DMS)

  12 months

• Change in average of Total Combined Rhinitis Score (TCRS)

  12 months

• To describe all adverse events (AE) and serious adverse events (SAE)

  up to 13 months

Other Outcomes (9)

• Change in Asthma Control Questionnaire (ACQ)

  12 months

• Change in the Forced Expiratory Volume in One Second (FEV1)

  12 months

• Change in the ratio of FEV1 and the Force Vital Capacity (FVC)

  12 months

Study Arms (1)

Standardised allergen extract from house dust mites (ACARIZAX®)

Observational study to collect real-world data: patients will be treated with ACARIZAX house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for one tablet per day.

Drug: Standardised allergen extract from house dust mites

Interventions

Standardised allergen extract from house dust mites DRUG

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.

Also known as: ACARIZAX® (12-SQ HDM)

Standardised allergen extract from house dust mites (ACARIZAX®)

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation \[skin prick test and/or specific Immunoglobulin E (IgE)\] with at least one of the following conditions: * persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication * house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)

Qionghai, Hainan, 571400, China

Location

Study Officials

• Wei Tang, PhD, MD

  Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 30, 2023
• Study Start: November 21, 2023
• Primary Completion: May 20, 2025
• Study Completion: August 20, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)