Clinical trial NCT06151938: Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Allergic Rhinitis Due to House Dust Mite
Allergic Asthma
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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 with ACARIZAX® has been made, and only with the objective of collecting relevant data about clinical effectiveness and safety of treatment with ACARIZAX® under real-world conditions. No further medical procedures beyond standard care at the discretion of the attending physician are necessary for participation in this study.

Over the 13-month study (including 12-month of treatment), total of 5 scheduled visits will be documented: enrolment and first administration of ACARIZAX® (Visit 1, V0), and subsequent visits performed in 3-month intervals after the first administration at the third month (Visit 2, V1), sixth month (Visit 3, V2), ninth month (Visit 4, V3), and twelfth month (Visit 5, V4) respectively. The actual number and duration of follow-up visits are according to routine practice and may be changed at the physician's discretion. All adverse events (AE) will be collected from the first dose administration until 30 days after the last dose of ACARIZAX® (end of study).

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.

Primary outcomes:
measure: Correlation between three measurement instruments
timeFrame: 12 months
Secondary outcomes:
measure: Change in average of Daily Medication Score (DMS)
timeFrame: 12 months
measure: Change in average of Total Combined Rhinitis Score (TCRS)
timeFrame: 12 months
measure: To describe all adverse events (AE) and serious adverse events (SAE)
timeFrame: up to 13 months
Other outcomes:
measure: Change in Asthma Control Questionnaire (ACQ)
timeFrame: 12 months
measure: Change in the Forced Expiratory Volume in One Second (FEV1)
timeFrame: 12 months
measure: Change in the ratio of FEV1 and the Force Vital Capacity (FVC)
timeFrame: 12 months
measure: Change in the force mid-expiratory flow (FEF25-75%, FEF25%, FEF50%, FEF75%) value
timeFrame: 12 months
measure: Change in the Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: 12 months
measure: Total AR / (AR with AA) -related treatment costs
timeFrame: 12 months in a 3-month interval.
measure: AR / (AR with AA) -related treatment costs of each outpatient visit, emergency room visit, and hospitalization
timeFrame: 12 months in a 3-month interval
measure: Number of outpatient visit, emergency room visit, and hospitalization due to AR / (AR with AA)
timeFrame: 12 months in a 3-month interval
measure: Length of stay per hospitalization due to AR / (AR with AA)
timeFrame: 12 months in a 3-month interval
Locations:
city: Qionghai
country: China
facility: Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
state: Hainan
Study officials:
affiliation: Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
name: Wei Tang, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: