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

NCT ID: NCT04097223

Last Updated: 2022-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects with Pulmonary Disease, Chronic Obstructive

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Wismar, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1237-0092

Identifier Type: -

Identifier Source: org_study_id

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