Pulmonary Disease, Chronic ObstructiveNCT04097223

A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A retrospective analysis study in COPD patients for an exact follow-up period of 12 months (in subgroup analyses: 24 and 36 months); censoring of patients will only be done in case a patient died during the respective follow-up period. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 17,464 participants
Where: 1 siteGermany
Study dates: 20 Nov 2019to 1 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: A retrospective analysis of patients with Chronic Obstructive Pulmonary Disease (COPD) based on current German COPD guidleines.

Who may be able to join

All patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death
A patient will be included as an incident COPD patient if either a hospital documented at least one COPD diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD-10 J 44.-) or a specialist (pneumologist) documented at least 2 confirmed COPD diagnoses (above ICD-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; inclusion period is defined as lasting from 01/01/2014 until 30/06/2017
Patients should not have received any COPD diagnosis (ICD-10 J44.-) or any COPD-associated medication in the 12 months pre-index period
Patient should have, at date of incident COPD diagnosis (index date), an age of at least 40 years

Who cannot join

Patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (ICD-10: J45) by pneumologists

Trial locations and contacts

1 site in 1 country.

Germany1 site

Institute for pharmacoeconomics and pharmaceutical logistics e.V (IPAM)
Wismar, 23966

Other trials in Germany

About this study

Official title: Real-world Treatment of Newly Diagnosed COPD Patients: A Retrospective German Claims Data Analysis

Conditions: Pulmonary Disease, Chronic Obstructive
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04097223
Study group	Role	What they receive
Subjects with Pulmonary Disease, Chronic Obstructive		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

Secondary outcomes (14)

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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20191 Jul 2020

First posted20 Sep 2019
Study start20 Nov 2019
Primary completion1 Jul 2020
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 17,464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04097223
Sponsor's protocol ID: 1237-0092
Status last verified: Feb 2022
First submitted: 4 Sep 2019
Last updated: 24 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-world Treatment of Newly Diagnosed COPD Patients: A Retrospective German Claims Data Analysis
ClinicalTrials.gov ID: NCT04097223
Acronym / sponsor ID: 1237-0092
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 17,464 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Nov 2019 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 20 Sep 2019 (actual)
Results: Posted 9 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Subjects with Pulmonary Disease, Chronic Obstructive	–	–

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: A retrospective analysis of patients with Chronic Obstructive Pulmonary Disease (COPD) based on current German COPD guidleines.

Key inclusion criteria (4 listed)

All patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death
A patient will be included as an incident COPD patient if either a hospital documented at least one COPD diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD-10 J 44.-) or a specialist (pneumologist) documented at least 2 confirmed COPD diagnoses (above ICD-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; inclusion period is defined as lasting from 01/01/2014 until 30/06/2017
Patients should not have received any COPD diagnosis (ICD-10 J44.-) or any COPD-associated medication in the 12 months pre-index period
Patient should have, at date of incident COPD diagnosis (index date), an age of at least 40 years

Key exclusion criteria (1 listed)

Patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (ICD-10: J45) by pneumologists

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
Time frame: 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). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
Time frame: 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). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
Time frame: 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). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.
Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample
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 treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis.
Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
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 participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis. GERD: Gastroesophageal reflux disease.

14 secondary outcomes

Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample
Time frame: At index date.
Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)
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)
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
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
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
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
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
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
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
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 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 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
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
Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.

Results and safety

Results posted to the registry on 9 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COPD-FULL Sample	17,464	17,464

Primary outcome: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample

Time frame: Up to 12 months after the index date.. Number. Unit: Percentage of Patients

Measure	COPD-12 - First Line Therapy n = 8238	COPD-12 - Second Line Therapy n = 1325	COPD-12 - Third Line Therapy n = 213	COPD-12 - Fourth Line Therapy n = 0
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	–

Population analysed: 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.

Primary outcome: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample

Time frame: Up to 24 months after the index date.. Number. Unit: Percentage of Patients

Measure	COPD-24 - First Line Therapy n = 5484	COPD-24 - Second Line Therapy n = 1411	COPD-24 - Third Line Therapy n = 432	COPD-24 - Fourth Line Therapy n = 126
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

Population analysed: 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).

Primary outcome: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample

Time frame: Up to 36 months after the index date.. Number. Unit: Percentage of Patients

Measure	COPD-36 - First Line Therapy n = 2445	COPD-36 - Second Line Therapy n = 801	COPD-36 - Third Line Therapy n = 300	COPD-36 - Fourth Line Therapy n = 119
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

Population analysed: 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).

Primary outcome: Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample

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.. Mean (Standard Deviation). Unit: Treatment lines

Measure	COPD-FULL Sample n = 9981	COPD-12 Sample n = 8238	COPD-24 Sample n = 5484	COPD-36 Sample n = 2445
Value	1.39 (0.83)	1.43 (0.86)	1.51 (0.97)	1.61 (1.06)

Population analysed: 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.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: [All-cause Mortality]: Up to 48 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COPD-FULL Sample	0 of 0	0 of 0	5,238 of 17,464

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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

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COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample (time frame: Up to 12 months after the index date.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04097223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.