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

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Bronchiectasis

Treatments: Drug: macrolide therapy; Drug: inhaled corticosteroid therapy

Study type: Observational

Funder types: Other

Identifiers

NCT02714283

CER-1503-29191

Details and patient eligibility

About

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

Full 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.

Enrollment: 90,089 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90,089 participants in 1 patient group

Non-CF bronchiectasis patients

Description:

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).

Treatment:

Drug: inhaled corticosteroid therapy

Drug: macrolide therapy