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Trial record 7 of 43 for:    "Bronchial Disease" | "Azithromycin"

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

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ClinicalTrials.gov Identifier: NCT02714283
Recruitment Status : Completed
First Posted : March 21, 2016
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
National Jewish Health
COPD Foundation
Information provided by (Responsible Party):
Kevin Winthrop, 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

Condition or disease Intervention/treatment
Bronchiectasis 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.

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Study Type : Observational
Actual Enrollment : 90089 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis
Actual Study Start Date : October 28, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Steroids

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients within Medicare with a diagnosis of bronchiectasis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714283


Sponsors and Collaborators
Oregon Health and Science University
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
National Jewish Health
COPD Foundation
Investigators
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Principal Investigator: Kevin L Winthrop, MD, MPH Oregon Health and Science University
Study Director: Emily Henkle, PhD, MPH Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Kevin Winthrop, Oregon Health and Science University:

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Responsible Party: Kevin Winthrop, Associate Professor, Divisions of Infectious Diseases, and Public Health and Preventive Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02714283     History of Changes
Other Study ID Numbers: CER-1503-29191
First Posted: March 21, 2016    Key Record Dates
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kevin Winthrop, Oregon Health and Science University:
nontuberculous mycobacteria
corticosteroids
macrolides
antibiotics

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Erythromycin
Anti-Infective Agents
Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action