A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)

NCT ID: NCT04172701

Last Updated: 2022-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2020-12-31

Brief Summary

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Non-interventional, Single-country study based on existing data from medical records of COPD patients treated with LAMA or fixed dose combination of ICS/LABA

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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LAMA

Chronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.

Long-acting Muscarinic Antagonists (LAMA)

Intervention Type DRUG

drug

ICS/LABA

Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.

Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)

Intervention Type DRUG

drug

Interventions

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Long-acting Muscarinic Antagonists (LAMA)

drug

Intervention Type DRUG

Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)

drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with COPD \[based on ICD-10 code(J43.x-44.x except J430), as the primary or within the fourth secondary diagnosis and initiated LAMA or ICS/LABA more than twice a year from Jan 1, 2005 to Apr 30 2016\].
* Age \>55 years old

Exclusion Criteria

* Prescription history with any long acting bronchodilator for maintenance therapy (the patient should be inhaler naïve)
* Prescription history with ipratropium bromide
* Prescription history with Leukotriene receptor antagonist(LTRA) or ICS
* Patients with lung cancer, IPF, ILD or lung transplantation at the time of COPD diagnosis
Minimum Eligible Age

55 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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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

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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0205-0542

Identifier Type: -

Identifier Source: org_study_id

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