N/A
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
Bottom Line
View on ClinicalTrials.gov: NCT04097223 ↗Enrolled (actual)
17,464
Serious AEs
—
Results posted
Sep 2021
Primary outcome: Primary: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample — 35.6; 30.3; 29.1; 25.0 Percentage of Patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2020
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 | — |
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.
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.