Replication of the P04334 Asthma Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,288
- 试验地点
- 1
- 主要终点
- Time to first asthma exacerbation
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
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
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥12 years of age
- •A subject must have been using a medium daily dose of inhaled glucocorticosteroid (ICS) (either alone or in combination with a long-acting beta agonist (LABA)) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks prior to Screening. Medium daily doses of ICS are defined as follows:
- •>500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
- •>250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
- •>600 to 1000 mcg budesonide dry powder inhaler (DPI)
- •>1000 to 2000 mcg flunisolide
- •>250 to 500 mcg fluticasone
- •>1000 to 2000 mcg triamcinolone acetonide
- •Diagnosis of asthma
- •A female subject of childbearing potential must have been using a medically acceptable, adequate form of birth control.
排除标准
- •A subject who experiences an occurrence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit
- •Emergency room treatment for asthma deterioration requiring systemic corticosteroid therapy or hospitalization for management of airway obstruction within the 3 months before baseline
- •A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >10 pack-years
- •Visible evidence of oropharyngeal candidiasis at baseline or earlier
研究组 & 干预措施
Formoterol fumarate 10 mcg
Reference Group
干预措施: Formoterol fumarate 10 mcg (Drug)
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
Exposure Group
干预措施: Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID (Drug)
结局指标
主要结局
Time to first asthma exacerbation
时间窗: Through study completion (a median of 134-147 days)
次要结局
未报告次要终点
研究者
Shirley Vichy Wang
Assistant Professor
Brigham and Women's Hospital