Trial Outcomes & Findings for A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT04097223)
NCT ID: NCT04097223
Last Updated: 2022-02-24
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
17464 participants
Primary outcome timeframe
Up to 12 months after the index date.
Results posted on
2022-02-24
Participant Flow
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).
Only subjects that met all inclusion and none of the exclusion criteria were included in the study.
Participant milestones
| Measure |
COPD-FULL Sample
Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
|
|---|---|
|
Overall Study
STARTED
|
17464
|
|
Overall Study
COMPLETED
|
17464
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
COPD-FULL Sample
n=17464 Participants
Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up.
|
|---|---|
|
Age, Continuous
|
71.5 Years
STANDARD_DEVIATION 12.3 • n=17464 Participants
|
|
Sex/Gender, Customized
Female
|
41.4 Percentage of participants
n=17464 Participants
|
|
Sex/Gender, Customized
Male
|
58.6 Percentage of participants
n=17464 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after the index date.Population: All patients included in the COPD-12 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive). The number of patients who received COPD-12 Fourth Line Therapy is less than 5% of the patient population (N=8238). As defined in the protocol, data collected only for treatment pattern combinations that were observed in \>5% in patient population.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=8238 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=1325 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=213 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
LAMA + ICS
|
16.3 Percentage of Patients
|
14.3 Percentage of Patients
|
13.6 Percentage of Patients
|
—
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
LABA + LAMA
|
35.6 Percentage of Patients
|
30.3 Percentage of Patients
|
29.1 Percentage of Patients
|
—
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
LAMA
|
25.0 Percentage of Patients
|
11.3 Percentage of Patients
|
10.3 Percentage of Patients
|
—
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
LABA
|
8.5 Percentage of Patients
|
5.4 Percentage of Patients
|
5.6 Percentage of Patients
|
—
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
LABA + LAMA + ICS
|
8.1 Percentage of Patients
|
24.8 Percentage of Patients
|
25.8 Percentage of Patients
|
—
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
ICS
|
4.2 Percentage of Patients
|
4.8 Percentage of Patients
|
6.1 Percentage of Patients
|
—
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine)
|
2.3 Percentage of Patients
|
9.0 Percentage of Patients
|
9.4 Percentage of Patients
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 months after the index date.Population: All patients included in the COPD-24 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive).
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=5484 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=1411 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=432 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=126 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
LABA + LAMA
|
34.4 Percentage of Patients
|
30.6 Percentage of Patients
|
25.0 Percentage of Patients
|
25.4 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
LAMA
|
24.6 Percentage of Patients
|
11.6 Percentage of Patients
|
11.3 Percentage of Patients
|
10.3 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
LAMA + ICS
|
17.3 Percentage of Patients
|
15.2 Percentage of Patients
|
13.7 Percentage of Patients
|
15.1 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
LABA
|
9.2 Percentage of Patients
|
5.0 Percentage of Patients
|
5.6 Percentage of Patients
|
4.8 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
LABA + LAMA + ICS
|
7.5 Percentage of Patients
|
24.9 Percentage of Patients
|
28.7 Percentage of Patients
|
23.9 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
ICS
|
4.9 Percentage of Patients
|
4.6 Percentage of Patients
|
4.9 Percentage of Patients
|
4.8 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine)
|
2.2 Percentage of Patients
|
8.2 Percentage of Patients
|
10.9 Percentage of Patients
|
15.9 Percentage of Patients
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 36 months after the index date.Population: All patients included in the COPD-36 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive).
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=2445 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=801 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=300 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=119 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
LABA + LAMA
|
31.3 Percentage of Patients
|
32.2 Percentage of Patients
|
27.7 Percentage of Patients
|
29.4 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
LAMA
|
25.2 Percentage of Patients
|
12.5 Percentage of Patients
|
12.3 Percentage of Patients
|
4.2 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
LAMA + ICS
|
17.8 Percentage of Patients
|
15.5 Percentage of Patients
|
13.3 Percentage of Patients
|
16.0 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
LABA
|
9.3 Percentage of Patients
|
6.1 Percentage of Patients
|
7.0 Percentage of Patients
|
5.0 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
LABA + LAMA + ICS
|
7.9 Percentage of Patients
|
20.6 Percentage of Patients
|
24.3 Percentage of Patients
|
21.0 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
ICS
|
6.3 Percentage of Patients
|
4.9 Percentage of Patients
|
5.0 Percentage of Patients
|
5.0 Percentage of Patients
|
—
|
—
|
|
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine)
|
2.2 Percentage of Patients
|
8.2 Percentage of Patients
|
10.3 Percentage of Patients
|
19.3 Percentage of Patients
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.Population: All patients with newly diagnosed (incident) COPD and who received any long-term COPD treatment. Incident COPD-patients are reported by follow-up period (12, 24, 36 and 48 months). Arms are not mutually exclusive.
Number of treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=9981 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8238 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=5484 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=2445 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample
|
1.39 Treatment lines
Standard Deviation 0.83
|
1.43 Treatment lines
Standard Deviation 0.86
|
1.51 Treatment lines
Standard Deviation 0.97
|
1.61 Treatment lines
Standard Deviation 1.06
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.Population: All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months). Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=17464 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=14213 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=8804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=3804 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
Beta-blocking agents
|
45.9 Percentage of participants
|
51.9 Percentage of participants
|
55.6 Percentage of participants
|
57.8 Percentage of participants
|
—
|
—
|
|
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
Anti-thrombotic agents
|
41.1 Percentage of participants
|
45.0 Percentage of participants
|
49.4 Percentage of participants
|
52.6 Percentage of participants
|
—
|
—
|
|
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
High-ceiling diurectis
|
37.9 Percentage of participants
|
40.4 Percentage of participants
|
43.3 Percentage of participants
|
43.7 Percentage of participants
|
—
|
—
|
|
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
Drugs for peptic ulcer or GERD
|
37.9 Percentage of participants
|
41.8 Percentage of participants
|
48.0 Percentage of participants
|
53.2 Percentage of participants
|
—
|
—
|
|
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
Other analgesics & antipyretics
|
20.3 Percentage of participants
|
20.5 Percentage of participants
|
29.7 Percentage of participants
|
36.7 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At index date.Population: All patients with newly diagnosed chronic obstructive pulmonary disease (COPD), with a follow-up of 12 months since index date (COPD-12).
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample
Any ICS containing therapy
|
14.1 Percentage of Patients
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample
LAMA + LABA combination
|
22.7 Percentage of Patients
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample
LABA + LAMA + ICS
|
4.7 Percentage of Patients
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At first day of triple therapy prescription, (which is not the index date), up to 12 months.Population: All patients included in the COPD-12 sample, who received triple therapy within the first 12 months after incident COPD.
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).
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=1019 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)
≤1 Outpatient diagnosis and no inpatient diagnosis indicating COPD related exacerbation
|
69 Percentage of Patients
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)
Documented FEV1 ≥50% value
|
75 Percentage of Patients
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months after index date.Population: All patients in the COPD-12 sample with treatment escalation in the first 12 months after index date.
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).
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=513 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy)
|
13 Percentage of Patients
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.Population: All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months), arms are not mutually exclusive.
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).
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=17464 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=14213 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=8804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=3804 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
≥ 1 exacerbation
|
12.0 Percentage of participants
|
10.1 Percentage of participants
|
11.0 Percentage of participants
|
12.2 Percentage of participants
|
—
|
—
|
|
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
1 exacerbation
|
9.8 Percentage of participants
|
8.0 Percentage of participants
|
8.5 Percentage of participants
|
9.5 Percentage of participants
|
—
|
—
|
|
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
2 exacerbation
|
1.5 Percentage of participants
|
1.4 Percentage of participants
|
1.7 Percentage of participants
|
1.8 Percentage of participants
|
—
|
—
|
|
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
3 exacerabation
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
0.5 Percentage of participants
|
—
|
—
|
|
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
≥ 3 exacerbation
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (COPD-12, COPD-24, COPD-36) and available Disease Management Program (DMP) data. Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=1434 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples
Number of yearly GP visits
|
4.58 Yearly visits
Standard Deviation 1.91
|
4.48 Yearly visits
Standard Deviation 1.69
|
4.45 Yearly visits
Standard Deviation 1.61
|
4.30 Yearly visits
Standard Deviation 1.91
|
—
|
—
|
|
Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples
Number of yearly pulmonologist visits
|
1.08 Yearly visits
Standard Deviation 1.57
|
1.00 Yearly visits
Standard Deviation 1.37
|
0.92 Yearly visits
Standard Deviation 1.27
|
2.76 Yearly visits
Standard Deviation 1.57
|
—
|
—
|
|
Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples
Number of yearly other specialist visits
|
7.73 Yearly visits
Standard Deviation 5.84
|
7.66 Yearly visits
Standard Deviation 5.50
|
7.67 Yearly visits
Standard Deviation 5.35
|
8.11 Yearly visits
Standard Deviation 5.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP) data. Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=1434 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
n=973 Participants
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
n=445 Participants
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples
Yearly hospitalizations with exacerbation (J44.1)
|
0.09 Yearly hospitalizations
Standard Deviation 0.34
|
0.06 Yearly hospitalizations
Standard Deviation 0.22
|
0.04 Yearly hospitalizations
Standard Deviation 0.16
|
0.11 Yearly hospitalizations
Standard Deviation 0.35
|
0.07 Yearly hospitalizations
Standard Deviation 0.24
|
0.05 Yearly hospitalizations
Standard Deviation 0.15
|
|
Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples
Yearly hospitalizations - any COPD diagnosis (J44)
|
0.17 Yearly hospitalizations
Standard Deviation 0.45
|
0.10 Yearly hospitalizations
Standard Deviation 0.28
|
0.08 Yearly hospitalizations
Standard Deviation 0.21
|
0.18 Yearly hospitalizations
Standard Deviation 0.44
|
0.12 Yearly hospitalizations
Standard Deviation 0.30
|
0.09 Yearly hospitalizations
Standard Deviation 0.21
|
|
Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples
Yearly hospitalizatons with non-COPD diagnosis
|
2.02 Yearly hospitalizations
Standard Deviation 2.08
|
1.38 Yearly hospitalizations
Standard Deviation 1.46
|
1.17 Yearly hospitalizations
Standard Deviation 1.22
|
1.09 Yearly hospitalizations
Standard Deviation 1.54
|
0.84 Yearly hospitalizations
Standard Deviation 1.06
|
0.74 Yearly hospitalizations
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP) data. Arms are not mutually exclusive.
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).
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14312 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=1434 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples
|
123 Days
Interval 49.0 to 228.0
|
207 Days
Interval 74.0 to 417.0
|
287 Days
Interval 98.0 to 585.0
|
141 Days
Interval 60.0 to 245.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP)-data. Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=1434 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
(Total) cost of outpatient visits (incl. costs for LTOT)
|
1093.80 Euro per Person-year
|
1059.52 Euro per Person-year
|
1052.53 Euro per Person-year
|
1179 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Total costs for GP visits
|
456.77 Euro per Person-year
|
446.63 Euro per Person-year
|
444.03 Euro per Person-year
|
429 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Total costs for pulmnologist visits
|
72.52 Euro per Person-year
|
67.30 Euro per Person-year
|
61.67 Euro per Person-year
|
185 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Total costs for other outpatient specialist visits
|
564.51 Euro per Person-year
|
545.59 Euro per Person-year
|
546.82 Euro per Person-year
|
565 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Inpatient cost (all-cause)
|
10936.50 Euro per Person-year
|
7013.81 Euro per Person-year
|
5766.66 Euro per Person-year
|
5508 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Total cost for hospitalizations with COPD-exacerbations
|
398.86 Euro per Person-year
|
228.28 Euro per Person-year
|
165.79 Euro per Person-year
|
414 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Total costs for hospitalizations with any COPD-diagnosis
|
755.57 Euro per Person-year
|
450.23 Euro per Person-year
|
349.47 Euro per Person-year
|
851 Euro per Person-year
|
—
|
—
|
|
Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
Total costs for hospitalizations with any non-COPD-diagnosis
|
10180.93 Euro per Person-year
|
6563.58 Euro per Person-year
|
5417.19 Euro per Person-year
|
4657 Euro per Person-year
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months). Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Beta-blocking agents
|
2.21 Yearly prescription (of medication)
Standard Deviation 2.49
|
2.16 Yearly prescription (of medication)
Standard Deviation 2.35
|
2.15 Yearly prescription (of medication)
Standard Deviation 2.29
|
—
|
—
|
—
|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Anti-thrombotic agents
|
2.06 Yearly prescription (of medication)
Standard Deviation 3.00
|
1.87 Yearly prescription (of medication)
Standard Deviation 2.37
|
1.80 Yearly prescription (of medication)
Standard Deviation 2.16
|
—
|
—
|
—
|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Other analgesics & antipyretics
|
1.07 Yearly prescription (of medication)
Standard Deviation 2.81
|
1.01 Yearly prescription (of medication)
Standard Deviation 2.43
|
0.93 Yearly prescription (of medication)
Standard Deviation 2.19
|
—
|
—
|
—
|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
High-ceiling diuretics
|
1.80 Yearly prescription (of medication)
Standard Deviation 2.55
|
1.67 Yearly prescription (of medication)
Standard Deviation 2.33
|
1.55 Yearly prescription (of medication)
Standard Deviation 2.21
|
—
|
—
|
—
|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Drugs for peptic ulcer or GERD
|
1.59 Yearly prescription (of medication)
Standard Deviation 2.11
|
1.56 Yearly prescription (of medication)
Standard Deviation 1.94
|
1.58 Yearly prescription (of medication)
Standard Deviation 1.88
|
—
|
—
|
—
|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Antibiotics for systemic use
|
0 Yearly prescription (of medication)
Standard Deviation 0
|
0.01 Yearly prescription (of medication)
Standard Deviation 0.02
|
0 Yearly prescription (of medication)
Standard Deviation 0
|
—
|
—
|
—
|
|
Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
Antibiotics + corticosteroids (ATC D07C)
|
0.03 Yearly prescription (of medication)
Standard Deviation 0.29
|
0.03 Yearly prescription (of medication)
Standard Deviation 0.24
|
0.03 Yearly prescription (of medication)
Standard Deviation 0.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months).
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).
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples
|
2338 Participants
|
1696 Participants
|
741 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.Population: Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP) data. Only patients with any observed LTOT are included.
Time from index date until start of long-term oxygen therapy (LTOT) in days in the first 12/24/36 months after incident diagnosis.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=2338 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=1696 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=741 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=269 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
n=223 Participants
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
n=93 Participants
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples
|
68.9 Days
Standard Deviation 99.6
|
160.2 Days
Standard Deviation 214.4
|
88.6 Days
Standard Deviation 206.8
|
64.5 Days
Standard Deviation 100.4
|
159.1 Days
Standard Deviation 216.2
|
202.1 Days
Standard Deviation 294.6
|
SECONDARY outcome
Timeframe: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.Population: All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months). Only patients with severe exacerbation leading to an inpatient hospitalization are included. Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=2102 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=1429 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=970 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=464 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36
|
42.8 Months
Standard Error 0.1
|
42.9 Months
Standard Error 0.1
|
43.3 Months
Standard Error 0.2
|
43.5 Months
Standard Error 0.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.Population: All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months). Arms are not mutually exclusive.
Average number of yearly exacerbations in the first 12/24/36 and 48 months after incident diagnosis.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=17464 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=14213 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=8804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
n=3804 Participants
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36
|
0.16 Exacerbations
Standard Deviation 0.57
|
0.14 Exacerbations
Standard Deviation 0.56
|
0.16 Exacerbations
Standard Deviation 0.64
|
0.18 Exacerbations
Standard Deviation 0.70
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.Population: All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients are reported by follow-up time (12, 24 and 36 months). Arms are not mutually exclusive.
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.
Outcome measures
| Measure |
COPD-12 - First Line Therapy
n=14213 Participants
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, who received first line therapy.
|
COPD-12 - Second Line Therapy
n=8804 Participants
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, who received second line therapy.
|
COPD-12 - Third Line Therapy
n=3804 Participants
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, who received third line therapy.
|
COPD-12 - Fourth Line Therapy
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, who received fourth line therapy.
|
COPD-24 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24).
|
COPD-36 Sample With DMP Data
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36).
|
|---|---|---|---|---|---|---|
|
Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36
Cost of COPD-medication (in total)
|
317.46 Euro per Year (€/Y)
Standard Deviation 392.69
|
292.03 Euro per Year (€/Y)
Standard Deviation 367.37
|
273.50 Euro per Year (€/Y)
Standard Deviation 361.06
|
—
|
—
|
—
|
|
Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36
Cost of non-COPD-medication (in total)
|
386.99 Euro per Year (€/Y)
Standard Deviation 713.16
|
355.92 Euro per Year (€/Y)
Standard Deviation 884.92
|
369.15 Euro per Year (€/Y)
Standard Deviation 2202.62
|
—
|
—
|
—
|
Adverse Events
COPD-FULL Sample
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5238 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER