An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Boehringer Ingelheim · Observational
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 17,464 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
A retrospective analysis of patients with Chronic Obstructive Pulmonary Disease (COPD) based on current German COPD guidleines.
Exclusion Criteria:
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-12 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date (COPD-12). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
Time frame: Up to 12 months after the index date.
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 24 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-24 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
Time frame: Up to 24 months after the index date.
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 36 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-36 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date (COPD-36). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
Time frame: Up to 36 months after the index date.
Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample
Number of treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis.
Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
Percentage of participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis. GERD: Gastroesophageal reflux disease.
Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample
Percentage of incident chronic obstructive pulmonary disease (COPD) patients with initial drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample. According to guidelines the initial treatment with long-acting bronchodilators should generally not include use of Inhaled corticosteroids (ICS) (both guidelines). Based on the 2012 guideline, a therapy with long-acting bronchodilators should not start with a combination of Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) or triple therapy of LAMA+LABA+ ICS.
Time frame: At index date.
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)
Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample, who received triple therapy (Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroids (ICS)) within the first 12 months after incident diagnosis. According to both guidelines (2012/2018) a triple combination treatment should not be prescribed if only 1 or less confirmed outpatient diagnoses and no inpatient diagnosis of a COPD exacerbation (ICD-10 J44.1) before date of prescription of a triple therapy. FEV1: Forced expiratory volume (in 1 second).
Time frame: At first day of triple therapy prescription, (which is not the index date), up to 12 months.
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy)
Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for patients in COPD-12 sample, with treatment escalation (mono therapy to Long-acting beta agonist (LABA)/ Long-acting muscarinic antagonist (LAMA)/ Inhaled corticosteroids (ICS), LABA/ICS or LAMA/LABA to LABA/LAMA/ICS) within the first 12 months after index date. According to guidelines patients should not receive a treatment intensification without any previous visit of a pneumologist or hospital (same quarter or previous quarter).
Time frame: Up to 12 months after index date.
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
Description of exacerbation (severe exacerbations associated with hospitalizations) frequency of patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12, 24, 36 and 48 months after incident diagnosis. Reported is the percentage of patients with exacerbations by the following categories: More or equal than one exacerbation (≥ 1) ; 1. exacerbation; 2. exacerbations; 3. exacerbations; more than 3 exacerbations (\> 3 exacerbations).
Time frame: Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples
Description of health-care resource use (HCRU) in the first 12/24/36 months after incident diagnosis - Number of yearly visits (outpatient treatment). Following categories are reported: Number of yearly general practitioner (GP) visits; Number of yearly pulmonologist visits; Number of yearly other specialist (primarily Ophthalmologist, Ear, Nose and Throat (ENT) specialist and Orthopedist) visits. Reported is the average number of yearly visits, per observed patient year.
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples
Description of health-care resource use in the first 12/24/36 months after incident diagnosis: Number of yearly hospitalizations (inpatient treatment). Following categories of inpatient treatment are reported: Number of yearly hospitalizations with exacerbations (J44.1); Number of yearly hospitalizations with exacerbations, any COPD diagnosis (J44); Number of yearly hospitalizations with non-COPD diagnosis. Results are reported by follow-up time and available Disease Management Program (DMP) data.
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples
Description of health-care resource use in the first 12/24/36 months after incident diagnosis in patients with chronic obstructive pulmonary disease (COPD). Reported is time to first all-cause hospitalization in days (inpatient treatment).
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Description of direct treatment cost in the first 12/24/36 months after incident diagnosis - yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. LTOT: Long-Term Oxygen Therapy.
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Prescription of medication. Top-5 prescription of non-COPD medication: Beta-blocking agents; Anti-thrombotic agents; Other analgesics \& antipyretics; High-ceiling diuretics; Drugs for peptic ulcer or Gastroesophageal reflux disease (GERD). Other prescriptions: Antibiotics for systemic use (ATC J02AA); Antibiotics + corticosteroids (ATC D07C). Reported is number of yearly prescription.
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples
Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Number of Patients with Long Term Oxygen Therapy (LTOT).
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples
Time from index date until start of long-term oxygen therapy (LTOT) in days in the first 12/24/36 months after incident diagnosis.
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36
Time from index date until first exacerbation, in the first 12/24/36/48 months after incident diagnosis. Only severe exacerbations leading to an inpatient hospitalization after index date (documented as main diagnosis: ICD-10 J44.1) are considered.
Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36
Average number of yearly exacerbations in the first 12/24/36 and 48 months after incident diagnosis.
Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36
Description of yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. Cost of non-COPD-medication are based on the top-10 prescribed on non-COPD drug therapies.
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.
A retrospective, non-interventional, longitudinal study including real-world data from german claims data (2015-2018) to describe the real-world drug treatment in patients of newly diagnosed chronic obstructive pulmonary disease (COPD).
| Milestone | COPD-FULL Sample |
|---|---|
| Started | 17464 |
| Completed | 17464 |
| Not completed | 0 |
Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-12 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date (COPD-12). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
| Percentage of Patients | COPD-12 - First Line Therapy | COPD-12 - Second Line Therapy | COPD-12 - Third Line Therapy | COPD-12 - Fourth Line Therapy |
|---|---|---|---|---|
| LABA + LAMA | 35.6 | 30.3 | 29.1 | — |
| LAMA | 25.0 | 11.3 | 10.3 | — |
| LAMA + ICS | 16.3 | 14.3 | 13.6 | — |
| LABA | 8.5 | 5.4 | 5.6 | — |
| LABA + LAMA + ICS | 8.1 | 24.8 | 25.8 | — |
| ICS | 4.2 | 4.8 | 6.1 | — |
| Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine) | 2.3 | 9.0 | 9.4 | — |
Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 24 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-24 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
| Percentage of Patients | COPD-24 - First Line Therapy | COPD-24 - Second Line Therapy | COPD-24 - Third Line Therapy | COPD-24 - Fourth Line Therapy |
|---|---|---|---|---|
| LABA + LAMA | 34.4 | 30.6 | 25.0 | 25.4 |
| LAMA | 24.6 | 11.6 | 11.3 | 10.3 |
| LAMA + ICS | 17.3 | 15.2 | 13.7 | 15.1 |
| LABA | 9.2 | 5.0 | 5.6 | 4.8 |
| LABA + LAMA + ICS | 7.5 | 24.9 | 28.7 | 23.9 |
| ICS | 4.9 | 4.6 | 4.9 | 4.8 |
| Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine) | 2.2 | 8.2 | 10.9 | 15.9 |
Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 36 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-36 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date (COPD-36). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
| Percentage of Patients | COPD-36 - First Line Therapy | COPD-36 - Second Line Therapy | COPD-36 - Third Line Therapy | COPD-36 - Fourth Line Therapy |
|---|---|---|---|---|
| LABA + LAMA | 31.3 | 32.2 | 27.7 | 29.4 |
| LAMA | 25.2 | 12.5 | 12.3 | 4.2 |
| LAMA + ICS | 17.8 | 15.5 | 13.3 | 16.0 |
| LABA | 9.3 | 6.1 | 7.0 | 5.0 |
| LABA + LAMA + ICS | 7.9 | 20.6 | 24.3 | 21.0 |
| ICS | 6.3 | 4.9 | 5.0 | 5.0 |
| Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine) | 2.2 | 8.2 | 10.3 | 19.3 |
Number of treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis.
| Treatment lines | COPD-FULL Sample | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|---|
| Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample | 1.39 ± 0.83 | 1.43 ± 0.86 | 1.51 ± 0.97 | 1.61 ± 1.06 |
Percentage of participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis. GERD: Gastroesophageal reflux disease.
| Percentage of participants | COPD-FULL Sample | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|---|
| Beta-blocking agents | 45.9 | 51.9 | 55.6 | 57.8 |
| Anti-thrombotic agents | 41.1 | 45.0 | 49.4 | 52.6 |
| High-ceiling diurectis | 37.9 | 40.4 | 43.3 | 43.7 |
| Drugs for peptic ulcer or GERD | 37.9 | 41.8 | 48.0 | 53.2 |
| Other analgesics & antipyretics | 20.3 | 20.5 | 29.7 | 36.7 |
Percentage of incident chronic obstructive pulmonary disease (COPD) patients with initial drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample. According to guidelines the initial treatment with long-acting bronchodilators should generally not include use of Inhaled corticosteroids (ICS) (both guidelines). Based on the 2012 guideline, a therapy with long-acting bronchodilators should not start with a combination of Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) or triple therapy of LAMA+LABA+ ICS.
| Percentage of Patients | COPD-12 Sample |
|---|---|
| Any ICS containing therapy | 14.1 |
| LAMA + LABA combination | 22.7 |
| LABA + LAMA + ICS | 4.7 |
Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample, who received triple therapy (Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroids (ICS)) within the first 12 months after incident diagnosis. According to both guidelines (2012/2018) a triple combination treatment should not be prescribed if only 1 or less confirmed outpatient diagnoses and no inpatient diagnosis of a COPD exacerbation (ICD-10 J44.1) before date of prescription of a triple therapy. FEV1: Forced expiratory volume (in 1 second).
| Percentage of Patients | COPD-12 Sample |
|---|---|
| ≤1 Outpatient diagnosis and no inpatient diagnosis indicating COPD related exacerbation | 69 |
| Documented FEV1 ≥50% value | 75 |
Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for patients in COPD-12 sample, with treatment escalation (mono therapy to Long-acting beta agonist (LABA)/ Long-acting muscarinic antagonist (LAMA)/ Inhaled corticosteroids (ICS), LABA/ICS or LAMA/LABA to LABA/LAMA/ICS) within the first 12 months after index date. According to guidelines patients should not receive a treatment intensification without any previous visit of a pneumologist or hospital (same quarter or previous quarter).
| Percentage of Patients | COPD-12 Sample |
|---|---|
| Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy) | 13 |
Description of exacerbation (severe exacerbations associated with hospitalizations) frequency of patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12, 24, 36 and 48 months after incident diagnosis. Reported is the percentage of patients with exacerbations by the following categories: More or equal than one exacerbation (≥ 1) ; 1. exacerbation; 2. exacerbations; 3. exacerbations; more than 3 exacerbations (\> 3 exacerbations).
| Percentage of participants | Overall COPD-sample | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|---|
| ≥ 1 exacerbation | 12.0 | 10.1 | 11.0 | 12.2 |
| 1 exacerbation | 9.8 | 8.0 | 8.5 | 9.5 |
| 2 exacerbation | 1.5 | 1.4 | 1.7 | 1.8 |
| 3 exacerabation | 0.4 | 0.4 | 0.4 | 0.5 |
| ≥ 3 exacerbation | 0.3 | 0.3 | 0.4 | 0.4 |
Description of health-care resource use (HCRU) in the first 12/24/36 months after incident diagnosis - Number of yearly visits (outpatient treatment). Following categories are reported: Number of yearly general practitioner (GP) visits; Number of yearly pulmonologist visits; Number of yearly other specialist (primarily Ophthalmologist, Ear, Nose and Throat (ENT) specialist and Orthopedist) visits. Reported is the average number of yearly visits, per observed patient year.
| Yearly visits | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample | COPD-12 Sample With DMP Data |
|---|---|---|---|---|
| Number of yearly GP visits | 4.58 ± 1.91 | 4.48 ± 1.69 | 4.45 ± 1.61 | 4.30 ± 1.91 |
| Number of yearly pulmonologist visits | 1.08 ± 1.57 | 1.00 ± 1.37 | 0.92 ± 1.27 | 2.76 ± 1.57 |
| Number of yearly other specialist visits | 7.73 ± 5.84 | 7.66 ± 5.50 | 7.67 ± 5.35 | 8.11 ± 5.84 |
Description of health-care resource use in the first 12/24/36 months after incident diagnosis: Number of yearly hospitalizations (inpatient treatment). Following categories of inpatient treatment are reported: Number of yearly hospitalizations with exacerbations (J44.1); Number of yearly hospitalizations with exacerbations, any COPD diagnosis (J44); Number of yearly hospitalizations with non-COPD diagnosis. Results are reported by follow-up time and available Disease Management Program (DMP) data.
| Yearly hospitalizations | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample | COPD-12 Sample With DMP Data | COPD-24 Sample With DMP Data | COPD-36 Sample With DMP Data |
|---|---|---|---|---|---|---|
| Yearly hospitalizations with exacerbation (J44.1) | 0.09 ± 0.34 | 0.06 ± 0.22 | 0.04 ± 0.16 | 0.11 ± 0.35 | 0.07 ± 0.24 | 0.05 ± 0.15 |
| Yearly hospitalizations - any COPD diagnosis (J44) | 0.17 ± 0.45 | 0.10 ± 0.28 | 0.08 ± 0.21 | 0.18 ± 0.44 | 0.12 ± 0.30 | 0.09 ± 0.21 |
| Yearly hospitalizatons with non-COPD diagnosis | 2.02 ± 2.08 | 1.38 ± 1.46 | 1.17 ± 1.22 | 1.09 ± 1.54 | 0.84 ± 1.06 | 0.74 ± 0.95 |
Description of health-care resource use in the first 12/24/36 months after incident diagnosis in patients with chronic obstructive pulmonary disease (COPD). Reported is time to first all-cause hospitalization in days (inpatient treatment).
| Days | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample | COPD-12 Sample With DMP Data |
|---|---|---|---|---|
| Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples | 123 (49 to 228) | 207 (74 to 417) | 287 (98 to 585) | 141 (60 to 245) |
Description of direct treatment cost in the first 12/24/36 months after incident diagnosis - yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. LTOT: Long-Term Oxygen Therapy.
| Euro per Person-year | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample | COPD-12 Patients With Available DMP-data |
|---|---|---|---|---|
| (Total) cost of outpatient visits (incl. costs for LTOT) | 1093.80 | 1059.52 | 1052.53 | 1179 |
| Total costs for GP visits | 456.77 | 446.63 | 444.03 | 429 |
| Total costs for pulmnologist visits | 72.52 | 67.30 | 61.67 | 185 |
| Total costs for other outpatient specialist visits | 564.51 | 545.59 | 546.82 | 565 |
| Inpatient cost (all-cause) | 10936.50 | 7013.81 | 5766.66 | 5508 |
| Total cost for hospitalizations with COPD-exacerbations | 398.86 | 228.28 | 165.79 | 414 |
| Total costs for hospitalizations with any COPD-diagnosis | 755.57 | 450.23 | 349.47 | 851 |
| Total costs for hospitalizations with any non-COPD-diagnosis | 10180.93 | 6563.58 | 5417.19 | 4657 |
Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Prescription of medication. Top-5 prescription of non-COPD medication: Beta-blocking agents; Anti-thrombotic agents; Other analgesics \& antipyretics; High-ceiling diuretics; Drugs for peptic ulcer or Gastroesophageal reflux disease (GERD). Other prescriptions: Antibiotics for systemic use (ATC J02AA); Antibiotics + corticosteroids (ATC D07C). Reported is number of yearly prescription.
| Yearly prescription (of medication) | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|
| Beta-blocking agents | 2.21 ± 2.49 | 2.16 ± 2.35 | 2.15 ± 2.29 |
| Anti-thrombotic agents | 2.06 ± 3.00 | 1.87 ± 2.37 | 1.80 ± 2.16 |
| Other analgesics & antipyretics | 1.07 ± 2.81 | 1.01 ± 2.43 | 0.93 ± 2.19 |
| High-ceiling diuretics | 1.80 ± 2.55 | 1.67 ± 2.33 | 1.55 ± 2.21 |
| Drugs for peptic ulcer or GERD | 1.59 ± 2.11 | 1.56 ± 1.94 | 1.58 ± 1.88 |
| Antibiotics for systemic use | 0 ± 0 | 0.01 ± 0.02 | 0 ± 0 |
| Antibiotics + corticosteroids (ATC D07C) | 0.03 ± 0.29 | 0.03 ± 0.24 | 0.03 ± 0.19 |
Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Number of Patients with Long Term Oxygen Therapy (LTOT).
| Participants | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|
| Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples | 2338 | 1696 | 741 |
Time from index date until start of long-term oxygen therapy (LTOT) in days in the first 12/24/36 months after incident diagnosis.
| Days | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample | COPD-12 Sample With DMP Data | COPD-24 Sample With DMP Data | COPD-36 Sample With DMP Data |
|---|---|---|---|---|---|---|
| Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples | 68.9 ± 99.6 | 160.2 ± 214.4 | 88.6 ± 206.8 | 64.5 ± 100.4 | 159.1 ± 216.2 | 202.1 ± 294.6 |
Time from index date until first exacerbation, in the first 12/24/36/48 months after incident diagnosis. Only severe exacerbations leading to an inpatient hospitalization after index date (documented as main diagnosis: ICD-10 J44.1) are considered.
| Months | COPD-FULL Sample | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|---|
| Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36 | 42.8 ± 0.1 | 42.9 ± 0.1 | 43.3 ± 0.2 | 43.5 ± 0.2 |
Average number of yearly exacerbations in the first 12/24/36 and 48 months after incident diagnosis.
| Exacerbations | COPD-FULL | COPD-12 | COPD-24 | COPD-36 |
|---|---|---|---|---|
| Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36 | 0.16 ± 0.57 | 0.14 ± 0.56 | 0.16 ± 0.64 | 0.18 ± 0.70 |
Description of yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. Cost of non-COPD-medication are based on the top-10 prescribed on non-COPD drug therapies.
| Euro per Year (€/Y) | COPD-12 Sample | COPD-24 Sample | COPD-36 Sample |
|---|---|---|---|
| Cost of COPD-medication (in total) | 317.46 ± 392.69 | 292.03 ± 367.37 | 273.50 ± 361.06 |
| Cost of non-COPD-medication (in total) | 386.99 ± 713.16 | 355.92 ± 884.92 | 369.15 ± 2202.62 |
Collected over [All-cause Mortality]: Up to 48 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COPD-FULL Sample | 5,238/17,464 (30%) | — | — |
Patients with newly diagnosed chronic obstructive pulmonary disease (Incident COPD patients).
| Age, Continuous(Years) | COPD-FULL Sample |
|---|---|
| Mean | 71.5 ± 12.3 |
| Sex/Gender, Customized(Percentage of participants) | COPD-FULL Sample |
|---|---|
| Female | 41.4 |
| Male | 58.6 |
| Race and Ethnicity Not Collected(Participants) | COPD-FULL Sample |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim