Once-Daily Single-Inhaler Triple Versus Dual Therapy in Patients With COPD (IMPACT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,281
- 试验地点
- 1
- 主要终点
- Annual rate of moderate or severe COPD exacerbations during treatment
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
- 40 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age
- •Established clinical history of COPD in accordance with the definition by the ATS/ERS
- •Receiving daily maintenance treatment for their COPD for at least 3 months prior to screening
- •A post-bronchodilator FEV1 < 50% predicted normal and a documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% ≤FEV1 < 80% predicted normal and a documented history of ≥ 2 moderate exacerbations or a documented history of ≥1 severe COPD exacerbation (hospitalized) in the previous 12 months.
排除标准
- •Pregnancy or child bearing potential without acceptable contraceptive method
- •Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
- •Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- •Subjects with lung volume reduction surgery within the 12 months prior to screening
- •Immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis)
- •Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
- •Other Respiratory tract infections that have not resolved at least 7 days prior to screening
- •Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
- •Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months
- •Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months
- •NYHA Class IV Heart failure
- •Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3L/min (Oxygen use less than or equal to 3L/min flow is not exclusionary.)
- •Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded
- •Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse
- •The use of any of the following medications under the given conditions:
- •Long term antibiotic use (short term antibiotics are allowed if treating short-term acute infection or short-term exacerbation
- •Use of a systemic, oral, or parenteral corticosteroid in the last 30 days (except unless treating COPD exacerbations/pneumonia)
研究组 & 干预措施
Fluticasone furoate-vilanterol
Reference group
干预措施: Fluticasone Furoate-Vilanterol Trifenatate (Drug)
Fluticasone furoate-umeclidinium-vilanterol
Exposure group
干预措施: Furoate-umeclidinium-vilanterol (Drug)
结局指标
主要结局
Annual rate of moderate or severe COPD exacerbations during treatment
时间窗: To study completion or censoring, up to 32 months
Claims-based algorithm: see attached protocol for full definition
次要结局
未报告次要终点
研究者
Shirley Vichy Wang
Assistant Professor
Brigham and Women's Hospital