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

NCT02714283 | Completed Results

• 1 other identifier: CER-1503-29191
• Study Type: observational
• Target: 90,089
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bronchiectasis

Keywords

nontuberculous mycobacteria; corticosteroids; macrolides; antibiotics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Sudden Cardiac Arrest

  up to 8 years

• Sensorineural Hearing Loss

  up to 8 years

• Hip Fracture

  up to 8 years

• Opportunistic Infections

  up to 8 years

• All-cause Mortality

  up to 8 years

Study Arms (1)

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; Drug: macrolide therapy

Interventions

inhaled corticosteroid therapy DRUG

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

Non-CF bronchiectasis patients

macrolide therapy DRUG

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

Also known as: azithromycin, erythromycin

Non-CF bronchiectasis patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients within Medicare with a diagnosis of bronchiectasis

You may qualify if:

• Within Medicare data, indicated diagnosis of Bronchiectasis by a Pulmonologist (ICD-9 code 494.0 and/or 494.1)

You may not qualify if:

• cystic fibrosis diagnosis, HIV infection, history of organ transplant

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Alabama at Birmingham: collaborator
• National Jewish Health: collaborator
• COPD Foundation: collaborator

Related Publications (3)

• 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.

  PMID: 1607900 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  PMID: 31000676 RESULT

MeSH Terms

Conditions

Bronchiectasis

Interventions

Azithromycin; Erythromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

Claims-based data limits our ability to confirm bronchiectasis diagnoses and include disease symptoms/severity in our models. Results may not be applicable to \<65 year old bronchiectasis patients who have a lower underlying risk of pneumonia.

Results Point of Contact

• Title: Emily Henkle, PhD, MPH
• Organization: Oregon Health & Science University

henkle@ohsu.edu

503-494-6226

Study Officials

• Kevin L Winthrop, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Emily Henkle, PhD, MPH

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Divisions of Infectious Diseases, and Public Health and Preventive Medicine

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 21, 2016
• Study Start: October 28, 2016
• Primary Completion: June 30, 2018
• Study Completion: July 1, 2018
• Last Updated: September 18, 2019
• Results First Posted: July 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share