Clinical trial NCT04172701: A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
Official title: CITRUS Study (Comparing the Incidence Between Tiotropium and ICS/LABA in Real World Use in South Korea)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 9284
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic obstrutive pulmonary disease

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate for the First Pneumonia Event
timeFrame: 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.
measure: Incidence Rate of Pneumonia Events
timeFrame: 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.
measure: Time to First Pneumonia Event From the Index Date
timeFrame: 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.
measure: Number of Patients With Pneumonia Event
timeFrame: 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.
measure: Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types)
timeFrame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types)
timeFrame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events
timeFrame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index Date
timeFrame: Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Incidence Rate of Initiating Triple Combination Therapy
timeFrame: 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.
measure: Number of Patients Who Initiated a Triple Combination Therapy
timeFrame: 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.
measure: Time to Initiating Triple Combination Therapy From the Index Date
timeFrame: 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:
measure: All-cause Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) (Visits Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Costs: Total Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Costs: Hospitalization Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Costs: Outpatient Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: All-cause Healthcare Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Total Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Hospitalization Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Outpatient Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted All-cause Costs: Total Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted All-cause Costs: Hospitalization Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted All-cause Costs: Outpatient Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted All-cause Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Total Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Hospitalization Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Outpatient Medical Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month)
timeFrame: Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
measure: Incidence Rate of All-cause Death
timeFrame: 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.
measure: Number of Patients With the Event All-cause Death
timeFrame: 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.
measure: Time to Death From the Index Date
timeFrame: 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.
measure: Incidence Rate of Tuberculosis (TB) Event
timeFrame: 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.
measure: Number of Patients With Tuberculosis (TB)
timeFrame: 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.
measure: Time to First Tuberculosis (TB) Event From the Index Date
timeFrame: 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.
measure: Incidence Rate of Lung Cancer
timeFrame: 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.
measure: Number of Patients With Lung Cancer
timeFrame: 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.
measure: Time to Occurrence of Lung Cancer From the Index Date
timeFrame: 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.
measure: Incidence Rate of Non-tuberculosis Mycobacteria (NTM) Lung Disease
timeFrame: 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.
measure: Number of Patients With Non-tuberculosis Mycobacteria (NTM) Lung Disease
timeFrame: 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.
measure: Time to Non-tuberculosis Mycobacteria (NTM) Lung Disease From the Index Date
timeFrame: 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.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References: