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

NCT ID: NCT02714283

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90089 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2018-07-01

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.

Conditions

Bronchiectasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

inhaled corticosteroid therapy

Intervention Type: DRUG

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

macrolide therapy

Intervention Type: DRUG

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

Interventions

inhaled corticosteroid therapy

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

Intervention Type: DRUG

macrolide therapy

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

Intervention Type: DRUG

Other Intervention Names

azithromycin; erythromycin

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: collaborator

COPD Foundation

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Winthrop

Associate Professor, Divisions of Infectious Diseases, and Public Health and Preventive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin L Winthrop, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Emily Henkle, PhD, MPH

Role: STUDY_DIRECTOR

Oregon Health and Science University

References

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.

Reference Type: BACKGROUND

PMID: 1607900 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3558716 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31000676 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CER-1503-29191

Identifier Type: -

Identifier Source: org_study_id