- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04172701
A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
CITRUS Study (Comparing the Incidence Between Tiotropium and ICS/LABA in Real World Use in South Korea)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 05030
- Konkuk University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with COPD [based on ICD-10 code(J43.x-44.x except J430), as the primary or within the fourth secondary diagnosis and initiated LAMA or ICS/LABA more than twice a year from Jan 1, 2005 to Apr 30 2016].
- Age >55 years old
Exclusion Criteria:
- Prescription history with any long acting bronchodilator for maintenance therapy (the patient should be inhaler naïve)
- Prescription history with ipratropium bromide
- Prescription history with Leukotriene receptor antagonist(LTRA) or ICS
- Patients with lung cancer, IPF, ILD or lung transplantation at the time of COPD diagnosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LAMA
Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.
|
drug
|
ICS/LABA
Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.
|
drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence Rate for the First Pneumonia Event
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary ~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. To assess the incidence of pneumonia event, the first pneumonia event observed during the follow-up period was considered. Incidence rate for the first pneumonia event was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Incidence Rate of Pneumonia Events
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary ~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. This outcome measure reports: Total number of pneumonia events/ sum of follow-up duration (person-years) for all participants |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Time to First Pneumonia Event From the Index Date
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary ~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. Date of pneumonia event was defined as the starting date of outpatient claim, or as the admission date of inpatient claim with the above 3 conditions to define pneumonia event. Mean and Standard Deviation of time to first pneumonia event from the index date was estimated using the Kaplan-Meier curve. |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of Patients With Pneumonia Event
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary ~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. Number of patients with pneumonia event is reported. |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types)
Time Frame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
To assess the incidence of COPD exacerbation event (all types), the first COPD exacerbation event among pre-defined moderate COPD exacerbation and severe COPD exacerbation event observed within the 12-month period after the index date was considered. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary ~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. Incidence rate of COPD exacerbation events (all types) was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/sum of event-free period during the follow-up period (1000 person-years) |
Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types)
Time Frame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
To assess the frequency of all types (moderate and severe) COPD exacerbation events, any events observed within the 12-month period after the index date was considered. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary ~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. Outcome measure reports: Total number of COPD exacerbation events (all types)/sum of follow-up duration (person-years) for all participants |
Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events
Time Frame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Number of patients with Chronic Obstructive Pulmonary Disease (COPD) exacerbation (moderate or severe) events is reported. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary ~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. |
Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index Date
Time Frame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of time to first COPD exacerbation (moderate or severe) event from the index date was estimated using the Kaplan-Meier curve. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary ~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. Date of severe COPD exacerbation event was defined as the starting date of ER claims or admission date of inpatient claims with the above 2 conditions to define moderate COPD exacerbation event. |
Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Incidence Rate of Initiating Triple Combination Therapy
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
To assess the incidence rate of initiating triple combination therapy, the first triple combination therapy observed during the follow-up period was considered. Triple combination therapy of inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA) was defined as ≥ 1 outpatient or inpatient claims with a combination of ICS, LABA, and LAMA. Three components of ICS, LABA and LAMA MUST have been prescribed together in a same prescription issued on same date to be considered as triple combination therapy (i.e. ICS/LABA fixed dose combination (FDC) and LAMA, ICS and LABA/LAMA FDC, ICS/LABA FDC and LABA/LAMA FDC, ICS and LABA and LAMA are all considered as triple combination therapy). Incidence rate of initiating triple combination therapy is reported as: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of Patients Who Initiated a Triple Combination Therapy
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of patients who initiated a triple combination therapy is reported.
Triple combination therapy of inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA) was defined as ≥ 1 outpatient or inpatient claims with a combination of ICS, LABA, and LAMA.
Three components of ICS, LABA and LAMA MUST have been prescribed together in a same prescription issued on same date to be considered as triple combination therapy (i.e.
ICS/LABA fixed dose combination (FDC) and LAMA, ICS and LABA/LAMA FDC, ICS/LABA FDC and LABA/LAMA FDC, ICS and LABA and LAMA are all considered as triple combination therapy).
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Time to Initiating Triple Combination Therapy From the Index Date
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Median and Inter-Quartile Range of time to initiating triple combination therapy from the index date was estimated using the Kaplan-Meier curve. Triple combination therapy of inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA) was defined as ≥ 1 outpatient or inpatient claims with a combination of ICS, LABA, and LAMA. Three components of ICS, LABA and LAMA MUST have been prescribed together in a same prescription issued on same date to be considered as triple combination therapy (i.e. ICS/LABA fixed dose combination (FDC) and LAMA, ICS and LABA/LAMA FDC, ICS/LABA FDC and LABA/LAMA FDC, ICS and LABA and LAMA are all considered as triple combination therapy). Date of triple combination therapy was defined as the starting date of outpatient claim or admission date of inpatient claim with a combination of ICS/LABA and LAMA. |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of any medical visit per person per month is reported.
Medical visits were calculated as the sum of inpatient and outpatient visits assuming that emergency room (ER) visits, intensive care unit (ICU) visits and visit for pharmacy dispensation would be counted with the inclusion of inpatient and outpatient visit.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of outpatient visits per person per month is reported.
Outpatient visit was defined as clinic, hospital, or other medical institution (e.g.
public health, etc.) visit as an outpatient.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of inpatient visits per person per month is reported.
Inpatient visit was defined as at least 1 overnight stay in a hospital as an inpatient.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of ER visits per person per month is reported.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of ICU visits per person per month is reported.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
COPD-related HCRU was defined as medical claims with ICD-10 codes for COPD and/or COPD-related diseases.
Mean and Standard Deviation of any medical visit (inpatient and outpatient visits which include emergency room (ER) and intensive care unit (ICU) visits) per person per month is reported.
For outpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD as primary ~ 4th secondary diagnosis.
For inpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD and/or for diseases due to COPD worsening as any diagnosis.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of outpatient visits per person per month is reported.
For outpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD as primary ~ 4th secondary diagnosis.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of inpatient visits per person per month is reported.
For inpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD and/or for diseases due to COPD worsening as any diagnosis.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) (Visits Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of ER visits per person per month is reported.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of ICU visits per person per month is reported.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Costs: Total Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of total medical costs per person per month is reported.
Total medical costs were estimated as the sum of medical costs (inpatient + outpatient) and pharmacy dispensation costs (drug cost + pharmacy service cost).
Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51
KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Costs: Hospitalization Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of hospitalization costs per person per month is reported.
Hospitalization costs were estimated as the total costs of services from all inpatient claims (e.g.
cost for procedure, diagnostic test, medication, patient meal, and bed stay, etc.).
Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51
KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Costs: Outpatient Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of outpatient medical costs per person per month is reported.
Outpatient medical costs were estimated as the total costs of services from all outpatient claims (e.g.
cost for procedure, diagnostic test, prescription, physician fee, etc.).
Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51
KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
All-cause Healthcare Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of outpatient pharmacy dispensation costs per person per month is reported.
Outpatient pharmacy dispensation costs were estimated as the total costs of services from all outpatient pharmacy claims (pharmacy dispensing service costs + medication costs).
Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51
KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Total Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of COPD-related total medical costs per person per month is reported.
COPD-related total medical costs were estimated as the sum of medical costs (inpatient + outpatient) of medical claims with ICD-10 codes for COPD and/or COPD-related diseases and pharmacy dispensation costs (drug costs + pharmacy service costs) of pharmacy claims including dispensation of ICS/LABA, LABA, LAMA, LABA/LAMA, short-acting beta-2 agonist (SABAs), short-acting muscarinic antagonist (SAMAs), SABA/SAMA, theophlliyne, or Phosphodiesterase-4 (PDE4) inhibitor.
Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51
KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Hospitalization Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of COPD-related hospitalization costs per person per month is reported. COPD-related hospitalization costs were estimated as the total costs of services (e.g. costs for procedure, diagnostic test, medication, patient meal, and bed stay, etc.) from all inpatient claims (medical claims with ICD-10 codes for COPD and/or for diseases due to COPD worsening as any diagnosis). Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Outpatient Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of COPD-related outpatient medical costs per person per month is reported. COPD-related outpatient medical costs were estimated as the total costs of services (e.g. costs for procedure, diagnostic test, prescription, physician fee, etc.) from all outpatient claims (medical claims with ICD-10 codes for COPD as primary ~ 4th secondary diagnosis). Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and Standard Deviation of COPD-related outpatient pharmacy dispensation costs per person per month is reported. COPD related outpatient pharmacy dispensation costs were estimated as the total costs of services (pharmacy dispensing service costs + medication costs) from all outpatient pharmacy claims (pharmacy claims including dispensation of ICS/LABA, LABA, LAMA, LABA/LAMA, short-acting beta-2 agonist (SABAs), short-acting muscarinic antagonist (SAMAs), SABA/SAMA, theophlliyne, or Phosphodiesterase-4 (PDE4) inhibitor). Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted All-cause Costs: Total Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of adjusted all-cause total medical costs per person per month is reported. All-cause total medical costs were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Total medical cost were estimated as the sum of medical costs (inpatient + outpatient) and pharmacy dispensation costs (drug costs + pharmacy service costs). Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted All-cause Costs: Hospitalization Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of adjusted all-cause hospitalization costs per person per month. All-cause hospitalization costs were estimated as the total costs of services from all inpatient claims (e.g. costs for procedure, diagnostic test, medication, patient meal, and bed stay, etc.) and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted All-cause Costs: Outpatient Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of adjusted all-cause outpatient medical costs per person per month. All-cause outpatient medical costs were estimated as the total costs of services from all outpatient claims (e.g. costs for procedure, diagnostic test, prescription, physician fee, etc.) and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted All-cause Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of adjusted all-cause outpatient pharmacy dispensation costs per person per month is reported. All-cause outpatient pharmacy dispensation cost were estimated as the total costs of services from all outpatient pharmacy claims (pharmacy dispensing service costs + medication costs) and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Total Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of adjusted COPD-related total medical costs per person per month is reported. COPD-related total medical costs were estimated as the sum of medical costs (inpatient + outpatient) of medical claims with ICD-10 codes for COPD and/or COPD-related diseases and pharmacy dispensation costs (drug costs + pharmacy service costs) of pharmacy claims including dispensation of ICS/LABA, LABA, LAMA, LABA/LAMA, short-acting beta-2 agonist (SABAs), short-acting muscarinic antagonist (SAMAs), SABA/SAMA, theophlliyne, or Phosphodiesterase-4 (PDE4) inhibitor and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Hospitalization Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of COPD-related hospitalization costs per person per month is reported. COPD-related hospitalization costs were estimated as the total costs of services (e.g. costs for procedure, diagnostic test, medication, patient meal, and bed stay, etc.) from all inpatient claims (medical claims with ICD-10 codes for COPD and/or for diseases due to COPD worsening as any diagnosis and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Outpatient Medical Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of COPD-related outpatient medical costs (per person per month) is reported. COPD-related outpatient medical costs were estimated as the total costs of services (e.g. costs for procedure, diagnostic test, prescription, physician fee, etc.) from all outpatient claims (medical claims with ICD-10 codes for COPD as primary ~ 4th secondary diagnosis) and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period. Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51 KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea. |
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
Time Frame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Mean and 95% Confidence Interval of COPD-related outpatient pharmacy dispensation costs (per person per month) is reported.
COPD related outpatient pharmacy dispensation costs were estimated as the total costs of services (pharmacy dispensing service costs + medication costs) from all outpatient pharmacy claims (pharmacy claims including dispensation of ICS/LABA, LABA, LAMA, LABA/LAMA, short-acting beta-2 agonist (SABAs), short-acting muscarinic antagonist (SAMAs), SABA/SAMA, theophlliyne, or Phosphodiesterase-4 (PDE4) inhibitor) and were adjusted for baseline characteristics and healthcare resource utilization (HCRU) and healthcare costs occurred during baseline period Costs were converted to US dollars using the average 2019 exchange rate: US$ = 1166.51
KRW (South Korean won) and were also adjusted to calendar year 2019 using the Consumer Price Index of South Korea.
|
Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
|
Incidence Rate of All-cause Death
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Date of death event was defined as the date of death recorded in the National Health Information Database (NHID). Incidence rate of all-cause death was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of Patients With the Event All-cause Death
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of patients with the event all-cause death is reported.
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Time to Death From the Index Date
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Median and Inter-Quartile Range of time to death from the index date is reported.
Date of death event was defined as the date of death recorded in the National Health Information Database (NHID).
Time to death was estimated from the Kaplan-Meier curve.
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Incidence Rate of Tuberculosis (TB) Event
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. study end date), up to 136 months.
|
Tuberculosis (TB) was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for pulmonary TB recorded as any diagnosis, AND 2) with special benefit costs for TB patients during the following period after the index date. To assess the incidence of TB event, the first TB event observed during the follow-up period was considered. Incidence rate of TB was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. study end date), up to 136 months.
|
Number of Patients With Tuberculosis (TB)
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Tuberculosis (TB) was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for pulmonary TB recorded as any diagnosis, AND 2) with special benefit costs for TB patients during the following period after the index date.
Number of patients with tuberculosis (TB) is reported.
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Time to First Tuberculosis (TB) Event From the Index Date
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Median and Inter-Quartile Range of time to first tuberculosis (TB) event is reported.
Tuberculosis (TB) was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for pulmonary TB recorded as any diagnosis, AND 2) with special benefit costs for TB patients during the following period after the index date.
Date of TB was defined as the admission date of inpatient claim or the starting date of outpatient claim with the above 2 conditions to define TB event.
Median and Inter-Quartile Range of time to first tuberculosis (TB) event was estimated using the Kaplan-Meier curve.
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Incidence Rate of Lung Cancer
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Lung cancer was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for lung cancer recorded as any diagnosis, AND 2) with costs for patients with cancers during the following period after the index date. To assess the incidence of lung cancer event, the first lung cancer event observed during the follow-up period was considered. Incidence rate of lung cancer was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of Patients With Lung Cancer
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of patients with lung cancer is reported.
Lung cancer was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for lung cancer recorded as any diagnosis, AND 2) with costs for patients with cancers during the following period after the index date.
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Time to Occurrence of Lung Cancer From the Index Date
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Median and Inter-Quartile Range of time to occurrence of lung cancer from the index date. Lung cancer was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for lung cancer recorded as any diagnosis, AND 2) with costs for patients with cancers during the following period after the index date. Date of lung cancer diagnosis was defined as the admission date of inpatient claim or the starting date of outpatient claim with the above 2 conditions to define lung cancer event. |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Incidence Rate of Non-tuberculosis Mycobacteria (NTM) Lung Disease
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Non-tuberculosis mycobacteria (NTM) lung disease was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for NTM recorded as any diagnosis during the following period after the index date. To assess the incidence of NTM event, the first NTM event observed during the follow-up period was considered. Incidence rate of NTM lung disease was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of Patients With Non-tuberculosis Mycobacteria (NTM) Lung Disease
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Number of patients with non-tuberculosis mycobacteria (NTM) lung disease is reported.
NTM lung disease was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for NTM recorded as any diagnosis during the following period after the index date.
|
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Time to Non-tuberculosis Mycobacteria (NTM) Lung Disease From the Index Date
Time Frame: From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Median and Inter-Quartile Range of Time to non-tuberculosis mycobacteria (NTM) lung disease from the index date were estimated using the Kaplan-Meier curve. NTM lung disease was defined as ≥1 inpatient claims or outpatient claims 1) with ICD-10 codes for NTM recorded as any diagnosis during the following period after the index date. Date of NTM was defined as the admission date of inpatient claim or the starting date of outpatient claim with the above 1 condition to define NTM event. |
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0205-0542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Disease, Chronic Obstructive
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Long-acting Muscarinic Antagonists (LAMA)
-
Boehringer IngelheimCompleted
-
Hywel Dda Health BoardSwansea UniversityCompleted
-
Boehringer IngelheimHealthCore-NERICompleted
-
Daping Hospital and the Research Institute of Surgery...CompletedChronic Obstructive Pulmonary DiseaseChina
-
SanofiRegeneron PharmaceuticalsCompletedChronic Obstructive Pulmonary DiseaseSpain, Argentina, China, Mexico, Canada, Ukraine, Israel, Italy, Czechia, Korea, Republic of, Bulgaria, Chile, Denmark, Finland, Germany, Hungary, Japan, Poland, Romania, Russian Federation, Slovakia, Sweden, Turkey, United States
-
SanofiRegeneron PharmaceuticalsActive, not recruitingChronic Obstructive Pulmonary DiseaseGreece, Belgium, Spain, Argentina, Hungary, South Africa, United Kingdom, France, Latvia, Germany, Netherlands, Russian Federation, Ukraine, United States, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Lithuania, Me... and more
-
Chronic Obstructive Pulmonary Disease Trial Network...Recruiting
-
Boehringer IngelheimCompleted
-
Intra-Cellular Therapies, Inc.CompletedSchizophreniaUnited States
-
RWTH Aachen UniversityWithdrawn