Clinical trial NCT04097223: A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Real-world Treatment of Newly Diagnosed COPD Patients: A Retrospective German Claims Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 17464
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective analysis of patients with Chronic Obstructive Pulmonary Disease (COPD) based on current German COPD guidleines.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample
timeFrame: Up to 12 months after the index date.
measure: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample
timeFrame: Up to 24 months after the index date.
measure: Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample
timeFrame: Up to 36 months after the index date.
measure: Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample
timeFrame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
measure: Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples
timeFrame: 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:
measure: Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample
timeFrame: At index date.
measure: Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)
timeFrame: At first day of triple therapy prescription, (which is not the index date), up to 12 months.
measure: Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy)
timeFrame: Up to 12 months after index date.
measure: Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples
timeFrame: Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
measure: Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.
measure: Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36
timeFrame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
measure: Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36
timeFrame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.
measure: Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36
timeFrame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.
Other outcomes:
Locations:
city: Wismar
country: Germany
facility: Institute for pharmacoeconomics and pharmaceutical logistics e.V (IPAM)
Study officials:
References: