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

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: inhaled corticosteroid therapy; Drug: macrolide therapy

• Registration Number: NCT02714283
• Lead Sponsor: Oregon Health and Science University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Study Start: 2016-10-28
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-01
• Results First Submitted: 2018-10-01
• Results First Submitted QC: 2019-04-24
• Results First Posted: 2019-07-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90089

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-CF bronchiectasis patients	macrolide therapy	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).
Non-CF bronchiectasis patients	inhaled corticosteroid therapy	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).

Primary Outcome Measures

Name	Time	Method
Nontuberculous Mycobacterial (NTM) Disease	up to 8 years	Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease
Hospitalized Respiratory Infection	up to 8 years	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.

Secondary Outcome Measures

Name	Time	Method
Sensorineural Hearing Loss	up to 8 years	Sensorineural hearing loss.
Hemoptysis	up to 8 years	Hemoptysis event
Sudden Cardiac Arrest	up to 8 years	Myocardial infarction event
All-cause Hospitalization	up to 8 years	All-cause hospitalization.
Arrhythmia	up to 8 years	Arrhythmia (principal diagnosis)
Hip Fracture	up to 8 years	Hip fracture.
All-cause Mortality	up to 8 years	All-cause mortality.
Opportunistic Infections	up to 8 years	Opportunistic infections.