N/A
Completed N=9,284
A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04172701 ↗
Enrolled (actual)
9,284
Serious AEs
—
Results posted
Apr 2022
Primary outcomePrimary: Incidence Rate for the First Pneumonia Event — 109.82; 167.10 patients/1000 person-years — p=<0.0001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate for the First Pneumonia Event |
109.82; 167.10 | <0.0001 sig |
| PRIMARY Incidence Rate of Pneumonia Events |
182.51; 264.99 | <0.001 sig |
| PRIMARY Time to First Pneumonia Event From the Index Date |
544.96; 413.35 | <0.0001 sig |
| PRIMARY Number of Patients With Pneumonia Event |
501; 605 | <0.0001 sig |
| PRIMARY Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types) |
714.18; 827.77 | 0.0003 sig |
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types) |
1357.48; 1523.68 | 0.001 sig |
| PRIMARY Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events |
1170; 1285 | 0.0006 sig |
| PRIMARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index Date |
113.94; 111.92 | 0.00074 sig |
| PRIMARY Incidence Rate of Initiating Triple Combination Therapy |
80.98; 139.82 | <0.0001 sig |
| PRIMARY Number of Patients Who Initiated a Triple Combination Therapy |
383; 518 | <0.0001 sig |
| PRIMARY Time to Initiating Triple Combination Therapy From the Index Date |
281; 207 | <0.0001 sig |
| SECONDARY All-cause Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month) |
2.81; 2.73 | 0.2875 |
| SECONDARY All-cause Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month) |
2.75; 2.66 | 0.4602 |
| SECONDARY All-cause Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month) |
0.06; 0.07 | 0.0062 sig |
| SECONDARY All-cause Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) Visits (Per Person Per Month) |
0.03; 0.04 | 0.0002 sig |
| SECONDARY All-cause Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month) |
0.00; 0.01 | 0.4907 |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month) |
0.66; 0.60 | <0.001 sig |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month) |
0.63; 0.56 | <0.001 sig |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month) |
0.03; 0.03 | 0.543 |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) (Visits Per Person Per Month) |
0.01; 0.01 | 0.080 |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month) |
0.00; 0.00 | 0.363 |
| SECONDARY All-cause Healthcare Costs: Total Medical Costs (Per Person Per Month) |
441.08; 510.42 | <0.0001 sig |
| SECONDARY All-cause Healthcare Costs: Hospitalization Costs (Per Person Per Month) |
176.26; 208.40 | 0.0494 sig |
| SECONDARY All-cause Healthcare Costs: Outpatient Medical Costs (Per Person Per Month) |
92.44; 100.20 | 0.0091 sig |
| SECONDARY All-cause Healthcare Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month) |
172.38; 201.81 | <0.0001 sig |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Total Medical Costs (Per Person Per Month) |
243.82; 295.83 | <0.0001 sig |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Hospitalization Costs (Per Person Per Month) |
112.87; 132.22 | 0.7298 |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Outpatient Medical Costs (Per Person Per Month) |
21.19; 22.23 | 0.0093 sig |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month) |
109.75; 141.39 | <0.0001 sig |
| SECONDARY Adjusted All-cause Costs: Total Medical Costs (Per Person Per Month) |
403.08; 474.50 | <0.0001 sig |
| SECONDARY Adjusted All-cause Costs: Hospitalization Costs (Per Person Per Month) |
236.65; 282.58 | 0.0103 sig |
| SECONDARY Adjusted All-cause Costs: Outpatient Medical Costs (Per Person Per Month) |
77.41; 85.45 | 0.0030 sig |
| SECONDARY Adjusted All-cause Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month) |
161.18; 189.32 | <0.0001 sig |
| SECONDARY Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Total Medical Costs (Per Person Per Month) |
216.37; 267.32 | <0.0001 sig |
| SECONDARY Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Hospitalization Costs (Per Person Per Month) |
178.25; 216.31 | 0.0212 sig |
| SECONDARY Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Outpatient Medical Costs (Per Person Per Month) |
20.20; 20.72 | 0.5024 |
| SECONDARY Adjusted Chronic Obstructive Pulmonary Disease (COPD)-Related Costs: Outpatient Pharmacy Dispensation Costs (Per Person Per Month) |
112.35; 146.53 | <0.0001 sig |
| SECONDARY Incidence Rate of All-cause Death |
9.38; 10.09 | 0.7198 |
| SECONDARY Number of Patients With the Event All-cause Death |
51; 46 | 0.7341 |
| SECONDARY Time to Death From the Index Date |
609; 350 | 0.74 |
| SECONDARY Incidence Rate of Tuberculosis (TB) Event |
10.46; 10.46 | 0.9985 |
| SECONDARY Number of Patients With Tuberculosis (TB) |
56; 47 | 0.5097 |
| SECONDARY Time to First Tuberculosis (TB) Event From the Index Date |
1; 86 | 0.51 |
| SECONDARY Incidence Rate of Lung Cancer |
10.64; 11.74 | 0.6069 |
| SECONDARY Number of Patients With Lung Cancer |
57; 53 | 0.8960 |
| SECONDARY Time to Occurrence of Lung Cancer From the Index Date |
91; 231 | 0.9 |
| SECONDARY Incidence Rate of Non-tuberculosis Mycobacteria (NTM) Lung Disease |
5.00; 3.09 | 0.1354 |
| SECONDARY Number of Patients With Non-tuberculosis Mycobacteria (NTM) Lung Disease |
27; 14 | 0.1158 |
| SECONDARY Time to Non-tuberculosis Mycobacteria (NTM) Lung Disease From the Index Date |
129; 360.5 | 0.11 |
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
Data sourced from ClinicalTrials.gov (NCT04172701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.