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

Allergic Asthma Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06151938
• Other study ID #: NI-MT-08
• Status: Enrolling by invitation
• Start date: November 21, 2023
• Est. completion date: August 20, 2025

Study information

• Verified date: March 2024
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 20, 2025
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis Due to House Dust Mite
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

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.

Locations

Country	Name	City	State
China	Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Asthma Control Questionnaire (ACQ)	• Among patients with AR and AA, the change in Asthma Control Questionnaire (ACQ) from baseline to the 12th month of treatment (Visit 4).; [minimum: 0; maximum: 6; Higher score indicates worse asthma condition]	12 months
Other	Change in the Forced Expiratory Volume in One Second (FEV1)	• Among patients with AR and AA, the change in the Forced Expiratory Volume in One Second (FEV1) from baseline to the 12th month of treatment (Visit 4).	12 months
Other	Change in the ratio of FEV1 and the Force Vital Capacity (FVC)	• Among patients with AR and AA, the change in the ratio of FEV1 and the Force Vital Capacity (FVC), that is the FEV1/FVC, from baseline to the 12th month of treatment (Visit 4).	12 months
Other	Change in the force mid-expiratory flow (FEF25-75%, FEF25%, FEF50%, FEF75%) value	• Among patients with AR and AA, the change in the force mid-expiratory flow (FEF25-75%, FEF25%, FEF50%, FEF75%) value from baseline to the 12th month of treatment (Visit 4).	12 months
Other	Change in the Fractional Exhaled Nitric Oxide (FeNO)	• Among patients with AR and AA, the change in the Fractional Exhaled Nitric Oxide (FeNO) from baseline to the 12th month of treatment (Visit 4).	12 months
Other	Total AR / (AR with AA) -related treatment costs	To describe the total AR / (AR with AA) - related treatment costs	12 months in a 3-month interval.
Other	AR / (AR with AA) -related treatment costs of each outpatient visit, emergency room visit, and hospitalization	To describe the AR / (AR with AA) - related treatment costs and break down (if applicable) of each outpatient visit, emergency room visit, and hospitalization	12 months in a 3-month interval
Other	Number of outpatient visit, emergency room visit, and hospitalization due to AR / (AR with AA)	To describe the number of outpatient visit, emergency room visit, and hospitalization due to AR / (AR with AA)	12 months in a 3-month interval
Other	Length of stay per hospitalization due to AR / (AR with AA)	To describe the length of stay per hospitalization due to AR / (AR with AA)	12 months in a 3-month interval
Primary	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	Change in average of Daily Medication Score (DMS)	• The change in average of Daily Medication Score (DMS) for 7 consecutive days from baseline to 12th month of treatment (Visit 4).; [minimum: 0; maximum: 20; Higher score indicates more medication use]	12 months
Secondary	Change in average of Total Combined Rhinitis Score (TCRS)	• The change in average of Total Combined Rhinitis Score (TCRS) for 7 consecutive days from baseline to 12th month of treatment (Visit 4).; [TCRS= Rhinitis DSS+ Rhinitis DMS; minimum: 0; maximum: 24; Higher score indicates worse rhinitis symptoms and more rhinitis medication use]	12 months
Secondary	To describe all adverse events (AE) and serious adverse events (SAE)	• All AEs and SAEs from the study initiation to the end of study.	up to 13 months