ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 1,511
- 试验地点
- 12
- 主要终点
- Asthma exacerbation
研究概览
简要总结
ANCHOR is a prospective, phase IV, interventional, single-arm, open-label study of 1,500 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy.
详细描述
This study will primarily compare rates of asthma exacerbation during 12-month pre-switch period and 12-month post switch period among participants with asthma needing a rescue therapy. Other outcomes of interest for comparison between the pre- and post-switch periods include asthma-related oral corticosteroids (OCS) use, asthma exacerbation-related hospitalizations, emergency department (ED) visits, urgent care visits, outpatient visits, telehealth visits, and asthma-related and asthma exacerbation-related healthcare costs. The use of asthma control and rescue medications will be collected to understand treatment patterns in the real-world US context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and above as of enrollment date.
- •At least 1 diagnosis of asthma prior to the enrollment date documented in patient record.
- •At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date.
- •At least 1 severe asthma exacerbation within 12 months before enrollment date.
- •Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date.
- •Participants also need to meet each of the following inclusion criteria:
- •Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU).
- •Willingness to respond to quarterly safety inquiries.
- •Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text.
- •Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI).
排除标准
- •Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date.
- •Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use.
- •Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 21 days or longer.
- •History of albuterol and budesonide as rescue use within 12 months before enrollment date.
- •History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date.
- •For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.
研究组 & 干预措施
Albuterol and budesonide inhalation aerosol
Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period.
干预措施: Albuterol and budesonide inhalation aerosol (Drug)
结局指标
主要结局
Asthma exacerbation
时间窗: During 12-month pre-switch and 12-month post-switch periods
Annualized Severe Asthma exacerbation rate
次要结局
- Asthma exacerbation-related HCRU(During 12-month pre-switch and 12-mont post switch periods)
- Asthma exacerbation-related cost(During 12-month pre-switch and 12-month post-switch periods)
- Asthma-related cost(During 12-month pre-switch and 12-month post-switch periods)
- Asthma- related Oral Corticosteroid (OCS) use(During 12-month pre-switch and 12-month post-switch periods)
- Change in asthma exacerbation-related HCRU at health system level(During 12-month pre-switch and 12-month post-switch periods)