N/A
Completed N=17,464
A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04097223 ↗
Enrolled (actual)
17,464
Serious AEs
—
Results posted
Sep 2021
Primary outcomePrimary: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample — 35.6; 30.3; 29.1; 25.0 Percentage of Patients
Summary
A retrospective analysis study in COPD patients for an exact follow-up period of 12 months (in subgroup analyses: 24 and 36 months); censoring of patients will only be done in case a patient died during the respective follow-up period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample |
35.6; 30.3; 29.1; 25.0; 11.3; 10.3 | — |
| PRIMARY Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample |
34.4; 30.6; 25.0; 25.4; 24.6; 11.6 | — |
| PRIMARY Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample |
31.3; 32.2; 27.7; 29.4; 25.2; 12.5 | — |
| PRIMARY Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample |
1.39; 1.43; 1.51; 1.61 | — |
| PRIMARY Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples |
45.9; 51.9; 55.6; 57.8; 41.1; 45.0 | — |
| SECONDARY Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample |
14.1; 22.7; 4.7 | — |
| SECONDARY Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy) |
69; 75 | — |
| SECONDARY Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy) |
13 | — |
| SECONDARY Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples |
12.0; 10.1; 11.0; 12.2; 9.8; 8.0 | — |
| SECONDARY Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples |
4.58; 4.48; 4.45; 4.30; 1.08; 1.00 | — |
| SECONDARY Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples |
0.09; 0.06; 0.04; 0.11; 0.07; 0.05 | — |
| SECONDARY Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples |
123; 207; 287; 141 | — |
| SECONDARY Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples |
1093.80; 1059.52; 1052.53; 1179; 456.77; 446.63 | — |
| SECONDARY Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples |
2.21; 2.16; 2.15; 2.06; 1.87; 1.80 | — |
| SECONDARY Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples |
2338; 1696; 741 | — |
| SECONDARY Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples |
68.9; 160.2; 88.6; 64.5; 159.1; 202.1 | — |
| SECONDARY Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36 |
42.8; 42.9; 43.3; 43.5 | — |
| SECONDARY Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36 |
0.16; 0.14; 0.16; 0.18 | — |
| SECONDARY Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36 |
317.46; 292.03; 273.50; 386.99; 355.92; 369.15 | — |
Eligibility Criteria
Inclusion Criteria
- All patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death
- A patient will be included as an incident COPD patient if either a hospital documented at least one COPD diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD-10 J 44.-) or a specialist (pneumologist) documented at least 2 confirmed COPD diagnoses (above ICD-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; inclusion period is defined as lasting from 01/01/2014 until 30/06/2017
- Patients should not have received any COPD diagnosis (ICD-10 J44.-) or any COPD-associated medication in the 12 months pre-index period
- Patient should have, at date of incident COPD diagnosis (index date), an age of at least 40 years
Exclusion Criteria
- Patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (ICD-10: J45) by pneumologists
Data sourced from ClinicalTrials.gov (NCT04097223). 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.