Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90,089
- 主要终点
- Nontuberculous Mycobacterial (NTM) Disease
研究概览
简要总结
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
详细描述
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within Medicare data, indicated diagnosis of Bronchiectasis by a Pulmonologist (ICD-9 code 494.0 and/or 494.1)
排除标准
- •cystic fibrosis diagnosis, HIV infection, history of organ transplant
研究组 & 干预措施
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).
干预措施: inhaled corticosteroid therapy (Drug)
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).
干预措施: macrolide therapy (Drug)
结局指标
主要结局
Nontuberculous Mycobacterial (NTM) Disease
时间窗: up to 8 years
Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease
Hospitalized Respiratory Infection
时间窗: 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.
次要结局
- Hip Fracture(up to 8 years)
- All-cause Mortality(up to 8 years)
- Sensorineural Hearing Loss(up to 8 years)
- Hemoptysis(up to 8 years)
- Sudden Cardiac Arrest(up to 8 years)
- All-cause Hospitalization(up to 8 years)
- Opportunistic Infections(up to 8 years)
- Arrhythmia(up to 8 years)
研究者
Kevin Winthrop
Associate Professor, Divisions of Infectious Diseases, and Public Health and Preventive Medicine
Oregon Health and Science University