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

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA); Drug: Long-acting Muscarinic Antagonists (LAMA)

Study type: Observational

Funder types: Industry

Identifiers

NCT04172701

0205-0542

Details and patient eligibility

About

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

Enrollment: 9,284 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

9,284 participants in 2 patient groups

LAMA

Description:

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

Treatment:

Drug: Long-acting Muscarinic Antagonists (LAMA)

ICS/LABA

Description:

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.

Treatment:

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