Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
Overview
- Phase
- Not Applicable
- Intervention
- inhaled corticosteroid therapy
- Conditions
- Bronchiectasis
- Sponsor
- Oregon Health and Science University
- Enrollment
- 90089
- Primary Endpoint
- Nontuberculous Mycobacterial (NTM) Disease
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Kevin Winthrop
Associate Professor, Divisions of Infectious Diseases, and Public Health and Preventive Medicine
Oregon Health and Science University
Eligibility Criteria
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
Arms & Interventions
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).
Intervention: inhaled corticosteroid therapy
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).
Intervention: macrolide therapy
Outcomes
Primary Outcomes
Nontuberculous Mycobacterial (NTM) Disease
Time Frame: up to 8 years
Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease
Hospitalized Respiratory Infection
Time Frame: 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.
Secondary Outcomes
- 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)