GRANITE: Airsupra Effectiveness in the Real World A Retrospective Prevalent New-user Cohort Study to Describe Characteristics and Compare Effectiveness of Airsupra vs Albuterol, in Patients With Asthma Requiring Use of Rescue Therapy in a Real-world Setting in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,060
- 试验地点
- 1
- 主要终点
- Baseline demographics and clinical characteristics of patients receiving Airsupra and albuterol
研究概览
简要总结
The GRANITE study aims to evaluate the effectiveness of Airsupra versus albuterol in reducing asthma exacerbation risk in a real-world US population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least one prescription record (based on NDC or healthcare common procedure coding system [HCPCS] codes) of Airsupra (for Airsupra arm) or albuterol (for selected albuterol comparator arm) since January 2023
- •Patients with an asthma indication (indicated by an ICD-10-CM code J45.xx) within the 12 months prior to the index date identified by at least one of the following Health Plan Employer Data Information Set (HEDIS) criteria:
- •At least one IP claim with asthma as the principal admission diagnosis, At least one ED/urgent care claim with asthma as the principal diagnosis, At least four outpatient claims with asthma as one of the listed diagnoses AND at least two claims for any asthma medications (including any rescue or maintenance medications) within the 12 months prior to the index date, At least four prescriptions for any asthma medications within the 12 months prior to the index date;
- •Patients with at least one prescription record (based on NDC or HCPCS codes) of albuterol within the 12 months prior to the index date
- •Patients aged ≥18 years on the index date
- •Patients with ≥12 months of continuous insurance enrolment prior to and post index date
排除标准
- •Patients with at least one medical claim with an ICD-10 code within the 12 months prior to the index date for the following chronic respiratory conditions or other systematic inflammatory diseases routinely treated with SCS: COPD, cystic fibrosis, pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis, respiratory tract cancer, hypereosinophilic syndrome, Churg-Strauss syndrome, eosinophilic pneumonia, Wegener's granulomatosis, allergic bronchopulmonary aspergillosis, obesity hypoventilation syndrome, hyperventilation syndrome, alpha-1 antitrypsin deficiency, primary ciliary dyskinesia, vasculitis collagen vascular disease, systemic lupus erythematosus, scleroderma, rheumatoid arthritis, Sjogren's syndrome, psoriatic arthritis, or inflammatory bowel disease (ulcerative colitis and Crohn's disease)
- •Patients with maintenance OCS use within the 12 months prior to the index date, defined as use of OCS covering minimum 50% (6 months) in days' supply
- •Airsupra patients with a concomitant SABA prescription record on the index date
研究组 & 干预措施
Airsupra cohort
Eligible adults aged ≥18 years with asthma and at least one prescription for Airsupra
干预措施: None (Observational study) (Other)
Albuterol cohort
Eligible adults aged ≥18 years with asthma and at least one prescription for albuterol
干预措施: None (Observational study) (Other)
结局指标
主要结局
Baseline demographics and clinical characteristics of patients receiving Airsupra and albuterol
时间窗: Baseline period is 12 months prior to the index date
Patient characteristics including demographics, clinical characteristics, asthma treatments, dosing, adherence to maintenance, asthma exacerbations, HCRU, and asthma severity defined per GINA will be described during the 12-month baseline period using descriptive statistics.
Severe asthma exacerbations
时间窗: Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.
Number of patients with any severe asthma exacerbation and the rate of severe asthma exacerbation per person-year will be described during the follow-up period.
次要结局
- Annualized exposure to Systemic Corticosteroids (SCS)(Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.)
- Median time to first exacerbation(Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.)
- Total exposure for SCS and SCS bursts rates(Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.)
- Annualized exposure to ICS and SCS(Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.)
- Annualized exposure to Inhaled Corticosteroid (ICS)(Follow-up period for each patient starts the day after the index date and ends at the earliest date of: end of data period,end of continuous enrolment(after 12 months),switch to albuterol(Airsupra cohort),Airsupra (albuterol cohort),or death.)