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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive

• Study Type: Observational
• Enrollment (Actual): 17464

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with Pulmonary Disease, Chronic Obstructive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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) ; exacerbation;; exacerbations;; exacerbations; more than 3 exacerbations (> 3 exacerbations).	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.	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.	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).	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.	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.	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).	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.	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.	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.	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.	Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1237-0092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No