Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: inhaled corticosteroid therapy
* Drug: macrolide therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-CF bronchiectasis patients<br>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). | Drug: inhaled corticosteroid therapy<br>* We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies<br>Drug: macrolide therapy<br>* We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies<br>* Other names: erythromycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nontuberculous Mycobacterial (NTM) Disease | Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease | up to 8 years | 
| Hospitalized Respiratory Infection | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudden Cardiac Arrest | Myocardial infarction event | up to 8 years | 
| Sensorineural Hearing Loss | Sensorineural hearing loss. | up to 8 years | 
| Hip Fracture | Hip fracture. | up to 8 years | 
| Opportunistic Infections | Opportunistic infections. | up to 8 years | 
| All-cause Mortality | All-cause mortality. | up to 8 years | 
| All-cause Hospitalization | All-cause hospitalization. | up to 8 years | 
| Hemoptysis | Hemoptysis event | up to 8 years | 
| Arrhythmia | Arrhythmia (principal diagnosis) | up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nontuberculous mycobacteria, corticosteroids, macrolides, antibiotics