Pulmonary Disease, Chronic ObstructiveNCT04172701
A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in South Korea.
Trial summary
Non-interventional, Single-country study based on existing data from medical records of COPD patients treated with LAMA or fixed dose combination of ICS/LABA Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Long-acting Muscarinic Antagonists (LAMA) and Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)
- How many people
- 9,284 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with chronic obstrutive pulmonary disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CITRUS Study (Comparing the Incidence Between Tiotropium and ICS/LABA in Real World Use in South Korea)
Non-interventional, Single-country study based on existing data from medical records of COPD patients treated with LAMA or fixed dose combination of ICS/LABA
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Long-acting Muscarinic Antagonists (LAMA), Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting Muscarinic Antagonists (LAMA)Drug
drug
Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)Drug
drug
| Study group | Role | What they receive |
|---|---|---|
| LAMA | Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015. Receives: Drug: Long-acting Muscarinic Antagonists (LAMA) | |
| 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. Receives: Drug: Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate for the First Pneumonia Event
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)
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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)
Measured: 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)
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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).
Measured: 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
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.
Measured: 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 outcomes (38)
All-cause Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Mean and Standard Deviation of ER visits per person per month is reported.
Measured: 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)
Mean and Standard Deviation of ICU visits per person per month is reported.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Mean and Standard Deviation of ER visits per person per month is reported.
Measured: 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)
Mean and Standard Deviation of ICU visits per person per month is reported.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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)
Measured: 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
Number of patients with the event all-cause death is reported.
Measured: 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
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.
Measured: 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
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)
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start15 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172701
- Sponsor's protocol ID
- 0205-0542
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2019
- Last updated
- 7 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CITRUS Study (Comparing the Incidence Between Tiotropium and ICS/LABA in Real World Use in South Korea)
- ClinicalTrials.gov ID
- NCT04172701
- Acronym / sponsor ID
- 0205-0542
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,284 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 7 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional, Single-country study based on existing data from medical records of COPD patients treated with LAMA or fixed dose combination of ICS/LABA
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAMA | – | Drug: Long-acting Muscarinic Antagonists (LAMA)Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015. |
| ICS/LABA | – | Drug: Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic obstrutive pulmonary disease
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-acting Muscarinic Antagonists (LAMA)drug | Drug | LAMA |
| Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)drug | Drug | ICS/LABA |
Primary outcome
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)
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
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.
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.
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)
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
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.
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.
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)
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).
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.
38 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.