40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 SamplePrimary· Up to 12 months after the index date.
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).
LAB
LABA + LAMA
Group
Value
95% CI
COPD-12 - First Line Therapy
35.6
COPD-12 - Second Line Therapy
30.3
COPD-12 - Third Line Therapy
29.1
LAMA
Group
Value
95% CI
COPD-12 - First Line Therapy
25.0
COPD-12 - Second Line Therapy
11.3
COPD-12 - Third Line Therapy
10.3
LAMA + ICS
Group
Value
95% CI
COPD-12 - First Line Therapy
16.3
COPD-12 - Second Line Therapy
14.3
COPD-12 - Third Line Therapy
13.6
LABA
Group
Value
95% CI
COPD-12 - First Line Therapy
8.5
COPD-12 - Second Line Therapy
5.4
COPD-12 - Third Line Therapy
5.6
LABA + LAMA + ICS
Group
Value
95% CI
COPD-12 - First Line Therapy
8.1
COPD-12 - Second Line Therapy
24.8
COPD-12 - Third Line Therapy
25.8
ICS
Group
Value
95% CI
COPD-12 - First Line Therapy
4.2
COPD-12 - Second Line Therapy
4.8
COPD-12 - Third Line Therapy
6.1
Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine)
Group
Value
95% CI
COPD-12 - First Line Therapy
2.3
COPD-12 - Second Line Therapy
9.0
COPD-12 - Third Line Therapy
9.4
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 SamplePrimary· Up to 24 months after the index date.
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).
LAB
LABA + LAMA
Group
Value
95% CI
COPD-24 - First Line Therapy
34.4
COPD-24 - Second Line Therapy
30.6
COPD-24 - Third Line Therapy
25.0
COPD-24 - Fourth Line Therapy
25.4
LAMA
Group
Value
95% CI
COPD-24 - First Line Therapy
24.6
COPD-24 - Second Line Therapy
11.6
COPD-24 - Third Line Therapy
11.3
COPD-24 - Fourth Line Therapy
10.3
LAMA + ICS
Group
Value
95% CI
COPD-24 - First Line Therapy
17.3
COPD-24 - Second Line Therapy
15.2
COPD-24 - Third Line Therapy
13.7
COPD-24 - Fourth Line Therapy
15.1
LABA
Group
Value
95% CI
COPD-24 - First Line Therapy
9.2
COPD-24 - Second Line Therapy
5.0
COPD-24 - Third Line Therapy
5.6
COPD-24 - Fourth Line Therapy
4.8
LABA + LAMA + ICS
Group
Value
95% CI
COPD-24 - First Line Therapy
7.5
COPD-24 - Second Line Therapy
24.9
COPD-24 - Third Line Therapy
28.7
COPD-24 - Fourth Line Therapy
23.9
ICS
Group
Value
95% CI
COPD-24 - First Line Therapy
4.9
COPD-24 - Second Line Therapy
4.6
COPD-24 - Third Line Therapy
4.9
COPD-24 - Fourth Line Therapy
4.8
Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine)
Group
Value
95% CI
COPD-24 - First Line Therapy
2.2
COPD-24 - Second Line Therapy
8.2
COPD-24 - Third Line Therapy
10.9
COPD-24 - Fourth Line Therapy
15.9
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 SamplePrimary· Up to 36 months after the index date.
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).
LAB
LABA + LAMA
Group
Value
95% CI
COPD-36 - First Line Therapy
31.3
COPD-36 - Second Line Therapy
32.2
COPD-36 - Third Line Therapy
27.7
COPD-36 - Fourth Line Therapy
29.4
LAMA
Group
Value
95% CI
COPD-36 - First Line Therapy
25.2
COPD-36 - Second Line Therapy
12.5
COPD-36 - Third Line Therapy
12.3
COPD-36 - Fourth Line Therapy
4.2
LAMA + ICS
Group
Value
95% CI
COPD-36 - First Line Therapy
17.8
COPD-36 - Second Line Therapy
15.5
COPD-36 - Third Line Therapy
13.3
COPD-36 - Fourth Line Therapy
16.0
LABA
Group
Value
95% CI
COPD-36 - First Line Therapy
9.3
COPD-36 - Second Line Therapy
6.1
COPD-36 - Third Line Therapy
7.0
COPD-36 - Fourth Line Therapy
5.0
LABA + LAMA + ICS
Group
Value
95% CI
COPD-36 - First Line Therapy
7.9
COPD-36 - Second Line Therapy
20.6
COPD-36 - Third Line Therapy
24.3
COPD-36 - Fourth Line Therapy
21.0
ICS
Group
Value
95% CI
COPD-36 - First Line Therapy
6.3
COPD-36 - Second Line Therapy
4.9
COPD-36 - Third Line Therapy
5.0
COPD-36 - Fourth Line Therapy
5.0
Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine)
Group
Value
95% CI
COPD-36 - First Line Therapy
2.2
COPD-36 - Second Line Therapy
8.2
COPD-36 - Third Line Therapy
10.3
COPD-36 - Fourth Line Therapy
19.3
Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL SamplePrimary· 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 treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis.
Group
Value
95% CI
COPD-FULL Sample
1.39
± 0.83
COPD-12 Sample
1.43
± 0.86
COPD-24 Sample
1.51
± 0.97
COPD-36 Sample
1.61
± 1.06
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 SamplesPrimary· 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 participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis.
GERD: Gastroesophageal reflux disease.
Beta-blocking agents
Group
Value
95% CI
COPD-FULL Sample
45.9
COPD-12 Sample
51.9
COPD-24 Sample
55.6
COPD-36 Sample
57.8
Anti-thrombotic agents
Group
Value
95% CI
COPD-FULL Sample
41.1
COPD-12 Sample
45.0
COPD-24 Sample
49.4
COPD-36 Sample
52.6
High-ceiling diurectis
Group
Value
95% CI
COPD-FULL Sample
37.9
COPD-12 Sample
40.4
COPD-24 Sample
43.3
COPD-36 Sample
43.7
Drugs for peptic ulcer or GERD
Group
Value
95% CI
COPD-FULL Sample
37.9
COPD-12 Sample
41.8
COPD-24 Sample
48.0
COPD-36 Sample
53.2
Other analgesics & antipyretics
Group
Value
95% CI
COPD-FULL Sample
20.3
COPD-12 Sample
20.5
COPD-24 Sample
29.7
COPD-36 Sample
36.7
Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 SampleSecondary· At index date.
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.
Any ICS containing therapy
Group
Value
95% CI
COPD-12 Sample
14.1
LAMA + LABA combination
Group
Value
95% CI
COPD-12 Sample
22.7
LABA + LAMA + ICS
Group
Value
95% CI
COPD-12 Sample
4.7
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)Secondary· At first day of triple therapy prescription, (which is not the index date), up to 12 months.
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
≤1 Outpatient diagnosis and no inpatient diagnosis indicating COPD related exacerbation
Group
Value
95% CI
COPD-12 Sample
69
Documented FEV1 ≥50% value
Group
Value
95% CI
COPD-12 Sample
75
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy)Secondary· Up to 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 quarte
Group
Value
95% CI
COPD-12 Sample
13
Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL SamplesSecondary· Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
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).
≥ 1 exacerbation
Group
Value
95% CI
Overall COPD-sample
12.0
COPD-12 Sample
10.1
COPD-24 Sample
11.0
COPD-36 Sample
12.2
1 exacerbation
Group
Value
95% CI
Overall COPD-sample
9.8
COPD-12 Sample
8.0
COPD-24 Sample
8.5
COPD-36 Sample
9.5
2 exacerbation
Group
Value
95% CI
Overall COPD-sample
1.5
COPD-12 Sample
1.4
COPD-24 Sample
1.7
COPD-36 Sample
1.8
3 exacerabation
Group
Value
95% CI
Overall COPD-sample
0.4
COPD-12 Sample
0.4
COPD-24 Sample
0.4
COPD-36 Sample
0.5
≥ 3 exacerbation
Group
Value
95% CI
Overall COPD-sample
0.3
COPD-12 Sample
0.3
COPD-24 Sample
0.4
COPD-36 Sample
0.4
Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 SamplesSecondary· Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
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.
Number of yearly GP visits
Group
Value
95% CI
COPD-12 Sample
4.58
± 1.91
COPD-24 Sample
4.48
± 1.69
COPD-36 Sample
4.45
± 1.61
COPD-12 Sample With DMP Data
4.30
± 1.91
Number of yearly pulmonologist visits
Group
Value
95% CI
COPD-12 Sample
1.08
± 1.57
COPD-24 Sample
1.00
± 1.37
COPD-36 Sample
0.92
± 1.27
COPD-12 Sample With DMP Data
2.76
± 1.57
Number of yearly other specialist visits
Group
Value
95% CI
COPD-12 Sample
7.73
± 5.84
COPD-24 Sample
7.66
± 5.50
COPD-36 Sample
7.67
± 5.35
COPD-12 Sample With DMP Data
8.11
± 5.84
Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 SamplesSecondary· Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
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 with exacerbation (J44.1)
Group
Value
95% CI
COPD-12 Sample
0.09
± 0.34
COPD-24 Sample
0.06
± 0.22
COPD-36 Sample
0.04
± 0.16
COPD-12 Sample With DMP Data
0.11
± 0.35
COPD-24 Sample With DMP Data
0.07
± 0.24
COPD-36 Sample With DMP Data
0.05
± 0.15
Yearly hospitalizations - any COPD diagnosis (J44)
Group
Value
95% CI
COPD-12 Sample
0.17
± 0.45
COPD-24 Sample
0.10
± 0.28
COPD-36 Sample
0.08
± 0.21
COPD-12 Sample With DMP Data
0.18
± 0.44
COPD-24 Sample With DMP Data
0.12
± 0.30
COPD-36 Sample With DMP Data
0.09
± 0.21
Yearly hospitalizatons with non-COPD diagnosis
Group
Value
95% CI
COPD-12 Sample
2.02
± 2.08
COPD-24 Sample
1.38
± 1.46
COPD-36 Sample
1.17
± 1.22
COPD-12 Sample With DMP Data
1.09
± 1.54
COPD-24 Sample With DMP Data
0.84
± 1.06
COPD-36 Sample With DMP Data
0.74
± 0.95
Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 SamplesSecondary· Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
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).
Group
Value
95% CI
COPD-12 Sample
123
49 – 228
COPD-24 Sample
207
74 – 417
COPD-36 Sample
287
98 – 585
COPD-12 Sample With DMP Data
141
60 – 245
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 24 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04097223.