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
Verified date | March 2024 |
Source | ALK-Abelló A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital) | Qionghai | Hainan |
Lead Sponsor | Collaborator |
---|---|
ALK-Abelló A/S |
China,
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 |
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