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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Alabama at Birmingham | OTHER |
| National Jewish Health | OTHER |
| COPD Foundation |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled corticosteroid therapy | Drug | We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sudden Cardiac Arrest | Myocardial infarction event | up to 8 years |
| Sensorineural Hearing Loss | Sensorineural hearing loss. | up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients within Medicare with a diagnosis of bronchiectasis
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| Name | Affiliation | Role |
|---|---|---|
| Kevin L Winthrop, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Emily Henkle, PhD, MPH | Oregon Health and Science University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1607900 | Background | 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. | |
| 3558716 | 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. |
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From the identified bronchiectasis cohort, we excluded patients with cystic fibrosis, HIV infection, or a history of organ transplant. Such patients are fundamentally different than non-CF bronchiectasis patients who lack these factors with regard to their risk for infection, hospitalization, and many of the outcomes under study in this proposal.
Complete national 2006-2014 Medicare data from Part A, B and D (but not C) were obtained from Center for Medicare and Medicaid Services for patients with ICD-9-CM code 494.0 or 494.1 (bronchiectasis without or with acute exacerbation).
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Corticosteroids (ICS) | New use was defined as the first prescription for a minimum 28 day ("chronic") supply of ICS after a clean period of 12 months with no chronic use of either exposure of interest. ICS included ICS alone or in combination with long-acting beta agonists. |
| FG001 | Macrolide Monotherapy | New use was defined as the first prescription for a minimum 28 day ("chronic") supply of macrolide monotherapy after a clean period of 12 months with no chronic use of either exposure of interest. Macrolide monotherapy was defined as oral azithromycin or erythromycin and no other chronic prescription within 30 days that could be associated with NTM therapy (ethambutol, a rifamycin, or a fluoroquinolone). Patients who did not start on macrolide monotherapy were excluded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Corticosteroids (ICS) | New use was defined as the first prescription for a minimum 28 day ("chronic") supply of ICS after a clean period of 12 months with no chronic use of either exposure of interest. ICS included ICS alone or in combination with long-acting beta agonists. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nontuberculous Mycobacterial (NTM) Disease | Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease | Analysis population excluded all patients with a history of NTM treatment or diagnosis prior to exposure start. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
This is a retrospective observational study. Only medical history data was collected.
All-Cause Mortality, Serious, and Other Adverse Events were not monitored. We report Safety Outcomes in the Outcomes section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-CF Bronchiectasis Patients on ICS Monotherapy | Patients prescribed a 28 day or more supply of ICS, with an absence of ICS prescriptions for at least the 12 months prior to identified prescription. ICS include beclomethasone, budesonide, flunisolide, fluticasone, mometasone, triamcinolone, ipratropium/albuterol, budesonide/formoterol, or fluticasone/salmeterol. Exclude baseline 28+ day macrolide, missing geographic or socioeconomic data. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Henkle, PhD, MPH | Oregon Health & Science University | 503-494-6226 | henkle@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2017 | Apr 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| OTHER |
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| macrolide therapy | Drug | We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies |
|
|
| Hip Fracture | Hip fracture. | up to 8 years |
| Opportunistic Infections | Opportunistic infections. | up to 8 years |
| All-cause Mortality | All-cause mortality. | up to 8 years |
| All-cause Hospitalization | All-cause hospitalization. | up to 8 years |
| Hemoptysis | Hemoptysis event | up to 8 years |
| Arrhythmia | Arrhythmia (principal diagnosis) | up to 8 years |
| 31000676 | Result | 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. |
| Macrolide Monotherapy |
New use was defined as the first prescription for a minimum 28 day ("chronic") supply of macrolide monotherapy after a clean period of 12 months with no chronic use of either exposure of interest. Macrolide monotherapy was defined as oral azithromycin or erythromycin and no other chronic prescription within 30 days that could be associated with NTM therapy (ethambutol, a rifamycin, or a fluoroquinolone). Patients who did not start on macrolide monotherapy were excluded. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Residential category | Count of Participants | Participants |
|
| Physician encounters in the 12 month prior to Baseline | Count of Participants | Participants |
|
| Pulmonologist encounters in the prior 12 months before baseline | Count of Participants | Participants |
|
| Inpatient admissions in the 12 months prior to baseline | Count of Participants | Participants |
|
| Hospitalized respiratory infections in the 12 months prior to baseline | Count of Participants | Participants |
|
| Number of acute respiratory infections in the 12 months prior to baseline | Count of Participants | Participants |
|
| Comorbidities (any history) | Count of Participants | Participants |
|
| Adapted Charlson comorbidity index (prior 12 months) | Charlson comorbidity index, higher score is worse. | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
|
|
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| Secondary | Sudden Cardiac Arrest | Myocardial infarction event | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
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|
|
| Secondary | Sensorineural Hearing Loss | Sensorineural hearing loss. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
|
|
|
| Secondary | Hip Fracture | Hip fracture. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
|
|
|
| Secondary | Opportunistic Infections | Opportunistic infections. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
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|
|
| Secondary | All-cause Mortality | All-cause mortality. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
|
|
|
| Secondary | All-cause Hospitalization | All-cause hospitalization. | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
|
|
|
| Secondary | Hemoptysis | Hemoptysis event | Posted | Number | Events | up to 8 years | Patient-years | Patient-years |
|
|
|
|
| Secondary | Arrhythmia | Arrhythmia (principal diagnosis) | Posted | Number | events | up to 8 years | person-years | person-years |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-CF Bronchiectasis Patients on Macrolide Monotherapy | Patients prescribed a 28 day or more supply of a macrolide, with an absence of macrolide prescriptions for at least the 12 months prior to identified prescription. Macrolides include oral azithromycin, clarithromycin, and erythromycin. Exclude baseline 28+ day ICS, missing geographic or socioeconomic data | 0 | 0 | 0 | 0 | 0 | 0 |
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