Trial · NCT04172701
A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
NCT04172701, Completed, Boehringer Ingelheim; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD). Trials, record NCT04172701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04172701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
- NCT number
- NCT04172701
- Status
- Completed
- Enrollment
- 9,284 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Long-acting Muscarinic Antagonists (LAMA), Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)
- First posted
- 2019-11-21
- Last updated
- 2022-04-07
- Results first posted
- 2022-04-07
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate for the First Pneumonia 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. | 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) |
| Primary | Incidence Rate of Pneumonia Events | 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 |
| Primary | Time to First Pneumonia Event From 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. | 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. |
| Primary | Number of Patients With Pneumonia 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. | 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. |
| Primary | Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types) | 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) |
| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types) | 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 |
| Primary | Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events | 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. |
| Primary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index Date | 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. |
| Primary | Incidence Rate of Initiating 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. | 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) |
| Primary | Number of Patients Who Initiated a 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. | 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). |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate for the First Pneumonia 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. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | patients/1000 person-years | NUMBER |
| PRIMARY | Incidence Rate of Pneumonia Events | 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. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | events/1000 person-years | NUMBER |
| PRIMARY | Time to First Pneumonia Event From 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. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | days | MEAN |
| PRIMARY | Number of Patients With Pneumonia 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. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types) | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | patients/1000 person-years | NUMBER |
| PRIMARY | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types) | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | events/1000 person-years | NUMBER |
| PRIMARY | Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index Date | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | days | MEAN |
| PRIMARY | Incidence Rate of Initiating 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. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | patients/1000 person-years | NUMBER |
| PRIMARY | Number of Patients Who Initiated a 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. | Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate for the First Pneumonia Event | LAMA | 109.82 | patients/1000 person-years | ||
| Incidence Rate for the First Pneumonia Event | ICS/LABA | 167.10 | patients/1000 person-years | ||
| Incidence Rate of Pneumonia Events | LAMA | 182.51 | events/1000 person-years | ||
| Incidence Rate of Pneumonia Events | ICS/LABA | 264.99 | events/1000 person-years | ||
| Time to First Pneumonia Event From the Index Date | LAMA | 544.96 | Standard Deviation 609.83 | days | |
| Time to First Pneumonia Event From the Index Date | ICS/LABA | 413.35 | Standard Deviation 475.8 | days | |
| Number of Patients With Pneumonia Event | LAMA | 501 | Participants | ||
| Number of Patients With Pneumonia Event | ICS/LABA | 605 | Participants | ||
| Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types) | LAMA | 714.18 | patients/1000 person-years | ||
| Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types) | ICS/LABA | 827.77 | patients/1000 person-years |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LAMA | 6,352 | |
| Overall Study | STARTED | ICS/LABA | 2,932 | |
| Overall Study | Propensity Score (PS) Matched Population | LAMA | 2,444 | |
| Overall Study | Propensity Score (PS) Matched Population | ICS/LABA | 2,444 | |
| Overall Study | COMPLETED | LAMA | 6,352 | |
| Overall Study | COMPLETED | ICS/LABA | 2,932 | |
| Overall Study | NOT COMPLETED | LAMA | 0 | |
| Overall Study | NOT COMPLETED | ICS/LABA | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LAMA | 51 | 2,444 |
| Total, all-cause mortality | ICS/LABA | 46 | 2,444 |
| Total, other adverse events | LAMA | 0 | 0 |
| Total, other adverse events | ICS/LABA | 0 | 0 |
| Total, serious adverse events | LAMA | 0 | 0 |
| Total, serious adverse events | ICS/LABA | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LAMA vs ICS/LABA: Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events | Trial comparisons |
| LAMA vs ICS/LABA: Number of Patients With Lung Cancer | Trial comparisons |
| LAMA vs ICS/LABA: Number of Patients With Tuberculosis (TB) | Trial comparisons |
| LAMA vs ICS/LABA: Number of Patients With the Event All-cause Death | Trial comparisons |
| LAMA vs ICS/LABA: Number of Patients With Pneumonia Event | Trial comparisons |
| LAMA vs ICS/LABA: Number of Patients With Non-tuberculosis Mycobacteria (NTM) Lung Disease | Trial comparisons |
| LAMA vs ICS/LABA: deaths from any cause | Trial comparisons |
| LAMA vs ICS/LABA: Number of Patients Who Initiated a Triple Combination Therapy | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04172701
GET https://conductscience.org/api/trials/v1/NCT04172701/registered?page=2