Clinical trial NCT02714283: Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
Official title: Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Keywords: nontuberculous mycobacteria
corticosteroids
macrolides
antibiotics
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Alabama at Birmingham
name: National Jewish Health
name: COPD Foundation
First posted: 2016-03-21
Enrollment: 90089
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients within Medicare with a diagnosis of bronchiectasis

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.

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

Primary outcomes:
measure: Nontuberculous Mycobacterial (NTM) Disease
timeFrame: up to 8 years
measure: Hospitalized Respiratory Infection
timeFrame: up to 8 years
Secondary outcomes:
measure: Sudden Cardiac Arrest
timeFrame: up to 8 years
measure: Sensorineural Hearing Loss
timeFrame: up to 8 years
measure: Hip Fracture
timeFrame: up to 8 years
measure: Opportunistic Infections
timeFrame: up to 8 years
measure: All-cause Mortality
timeFrame: up to 8 years
measure: All-cause Hospitalization
timeFrame: up to 8 years
measure: Hemoptysis
timeFrame: up to 8 years
measure: Arrhythmia
timeFrame: up to 8 years
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Kevin L Winthrop, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Emily Henkle, PhD, MPH
role: STUDY_DIRECTOR
References:
citation: Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992 Jun;45(6):613-9. doi: 10.1016/0895-4356(92)90133-8.
citation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
citation: Henkle E, Curtis JR, Chen L, Chan B, Aksamit TR, Daley CL, Griffith DE, Winthrop KL. Comparative risks of chronic inhaled corticosteroids and macrolides for bronchiectasis. Eur Respir J. 2019 Jul 18;54(1):1801896. doi: 10.1183/13993003.01896-2018. Print 2019 Jul.