Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
2019年9月4日 更新者：Kevin Winthrop、Oregon Health and Science University
The purpose of this study is to provide patients and their physicians with greater understanding of the risks and benefits of commonly used therapies for treatment of non-CF bronchiectasis
研究概览
详细说明
Non-CF bronchiectasis is a chronic inflammatory lung disease that is closely linked to pulmonary NTM disease.
Both are rare but rising in incidence and disproportionately affect the elderly and women.
Therapy of non-CF bronchiectasis aims to reduce inflammation via either ICS-induced immunosuppression or antibiotic-associated immunomodulation and/or suppression of pathogenic organisms.
Both strategies, pursued long-term alone or some cases concomitantly, have inherent risks, and the relative risks and benefits of these differential approaches are poorly studied to date.
Ultimately, our study will provide patients and their physicians with greater understanding of the risks and benefits of these therapeutic choices.
研究类型
观察性的
注册 (实际的)
90089
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients within Medicare with a diagnosis of bronchiectasis
描述
Inclusion Criteria:
- Within Medicare data, indicated diagnosis of Bronchiectasis by a Pulmonologist (ICD-9 code 494.0 and/or 494.1)
Exclusion Criteria:
- cystic fibrosis diagnosis, HIV infection, history of organ transplant
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Non-CF bronchiectasis patients
Complete national 2006-2014 Medicare data from Part A, B and D will be obtained from CMS.
We will use bronchiectasis ICD-9 codes 494.0 and 494.1 to identify patients with bronchiectasis within Medicare.
From this identified bronchiectasis cohort, we will exclude patients with cystic fibrosis (ICD-9 codes 277.00-277.09),
HIV infection (042), and a history of organ transplant (V42.0,
V42.1, V42.6, V42.7, V42.8).
|
We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies
We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Nontuberculous Mycobacterial (NTM) Disease
大体时间：up to 8 years
|
Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease
|
up to 8 years
|
|
Hospitalized Respiratory Infection
大体时间：up to 8 years
|
Among a national cohort of non-CF bronchiectasis patients, we will compare the effectiveness of corticosteroid and macrolide therapy with regards to prevention of hospitalized respiratory infection.
|
up to 8 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sudden Cardiac Arrest
大体时间：up to 8 years
|
Myocardial infarction event
|
up to 8 years
|
|
Sensorineural Hearing Loss
大体时间：up to 8 years
|
Sensorineural hearing loss.
|
up to 8 years
|
|
Hip Fracture
大体时间：up to 8 years
|
Hip fracture.
|
up to 8 years
|
|
Opportunistic Infections
大体时间：up to 8 years
|
Opportunistic infections.
|
up to 8 years
|
|
All-cause Mortality
大体时间：up to 8 years
|
All-cause mortality.
|
up to 8 years
|
|
All-cause Hospitalization
大体时间：up to 8 years
|
All-cause hospitalization.
|
up to 8 years
|
|
Hemoptysis
大体时间：up to 8 years
|
Hemoptysis event
|
up to 8 years
|
|
Arrhythmia
大体时间：up to 8 years
|
Arrhythmia (principal diagnosis)
|
up to 8 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Emily Henkle, PhD, MPH、Oregon Health and Science University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992 Jun;45(6):613-9. doi: 10.1016/0895-4356(92)90133-8.
- Henkle E, Curtis JR, Chen L, Chan B, Aksamit TR, Daley CL, Griffith DE, Winthrop KL. Comparative risks of chronic inhaled corticosteroids and macrolides for bronchiectasis. Eur Respir J. 2019 Jul 18;54(1):1801896. doi: 10.1183/13993003.01896-2018. Print 2019 Jul.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年10月28日
初级完成 (实际的)
2018年6月30日
研究完成 (实际的)
2018年7月1日
研究注册日期
首次提交
2016年3月15日
首先提交符合 QC 标准的
2016年3月15日
首次发布 (估计)
2016年3月21日
研究记录更新
最后更新发布 (实际的)
2019年9月18日
上次提交的符合 QC 标准的更新
2019年9月4日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.