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

Oregon Health and Science University90,089 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

90,089

Conditions

Bronchiectasis

Interventions

inhaled corticosteroid therapyDRUG

We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies

macrolide therapyDRUG

We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Nontuberculous Mycobacterial (NTM) Disease

Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease

Time frame: 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.

Time frame: up to 8 years

Secondary Outcomes

Sudden Cardiac Arrest

Myocardial infarction event

Time frame: up to 8 years

Sensorineural Hearing Loss

Sensorineural hearing loss.

Time frame: up to 8 years

Hip Fracture

Hip fracture.

Time frame: up to 8 years

Opportunistic Infections

Opportunistic infections.

Time frame: up to 8 years

All-cause Mortality

All-cause mortality.

Time frame: up to 8 years

All-cause Hospitalization

All-cause hospitalization.

Time frame: up to 8 years

Hemoptysis

Hemoptysis event

Time frame: up to 8 years

Data from ClinicalTrials.gov

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