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

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: inhaled corticosteroid therapy; Drug: macrolide therapy

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.

• Study Type: Observational
• Enrollment (Actual): 90089

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients within Medicare with a diagnosis of bronchiectasis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

Drug: inhaled corticosteroid therapy; We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies; Drug: macrolide therapy; We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies; Other Names: azithromycin; erythromycin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Patient-Centered Outcomes Research Institute; University of Alabama at Birmingham; National Jewish Health; COPD Foundation
• Investigators: Study Director: Emily Henkle, PhD, MPH, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: antibiotics; corticosteroids; macrolides; nontuberculous mycobacteria
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Azithromycin
• Other Study ID Numbers: CER-1503-29191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO