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OpenTrials
Completed

NCT Number: NCT02714283

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

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled corticosteroid therapy

Drug

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

macrolide therapy

Drug

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

Other names: azithromycin, erythromycin

Primary outcomes

  1. Nontuberculous Mycobacterial (NTM) Disease

    Time frame: up to 8 years

    Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease

  2. Hospitalized Respiratory Infection

    Time frame: 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 outcomes

  1. Sudden Cardiac Arrest

    Time frame: up to 8 years

    Myocardial infarction event

  2. Sensorineural Hearing Loss

    Time frame: up to 8 years

    Sensorineural hearing loss.

  3. Hip Fracture

    Time frame: up to 8 years

    Hip fracture.

  4. Opportunistic Infections

    Time frame: up to 8 years

    Opportunistic infections.

  5. All-cause Mortality

    Time frame: up to 8 years

    All-cause mortality.

  6. All-cause Hospitalization

    Time frame: up to 8 years

    All-cause hospitalization.

  7. Hemoptysis

    Time frame: up to 8 years

    Hemoptysis event

  8. Arrhythmia

    Time frame: up to 8 years

    Arrhythmia (principal diagnosis)

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • COPD Foundation
  • National Jewish Health
  • Patient-Centered Outcomes Research Institute
  • University of Alabama at Birmingham

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2016
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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