A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment

NCT ID: NCT04011475

Last Updated: 2022-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1617 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-29

Study Completion Date

2020-10-31

Brief Summary

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Study to collect the data on Chronic Obstructive Pulmonary Disease (COPD) patients who were administered with Long-Acting Beta-Agonist/ Long-Acting Muscarinic Antagonist (LABA/LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment

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 Tiotropium and Olodaterol

Tiotropium + Olodaterol

Intervention Type DRUG

Spiolto®

Subjects treated with other LABA/LAMA therapy

Other LABA/LAMA

Intervention Type DRUG

tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium

Subjects treated with LAMA therapy

LAMA

Intervention Type DRUG

aclidinium bromide, glycopyrronium, tiotropium, umeclidinium

Interventions

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Tiotropium + Olodaterol

Spiolto®

Intervention Type DRUG

Other LABA/LAMA

tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium

Intervention Type DRUG

LAMA

aclidinium bromide, glycopyrronium, tiotropium, umeclidinium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients who fulfil ALL the following criteria are included.

1. Patients who diagnosed with COPD who were prescribed with LABA/LABA (FDC or free combo) as a new initiation or switching from other therapy (i.e., single/dual/triple), or newly receiving LAMA treatment for 3 months at least prior to 30 June 2018
2. Male or female patients ≥ 40 years of age

Exclusion Criteria

1\. Patients who meet the following criterion are not included.

* Patients with documented diagnosis of bronchial asthma, asthma-COPD overlap syndrome (ACOS), bronchiectasis, cystic fibrosis, or lung cancer
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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Ditmanson Medical Foundation Chia - Yi Christian Hospital

Chia YI City, , Taiwan

Site Status

CGMH Chia YI

Chia YI City, , Taiwan

Site Status

Eda hospital

Kaohsiung City, , Taiwan

Site Status

CGMH Kaohsiung

Kaohsiung City, , Taiwan

Site Status

Far east memorial hospital

New Taipei City, , Taiwan

Site Status

China medicine memorial hospital

Taichung, , Taiwan

Site Status

VGH Taichung

Taichung, , Taiwan

Site Status

National Taiwan University hospital

Taipei, , Taiwan

Site Status

Makay memorial hospital

Taipei, , Taiwan

Site Status

Cheng Hsin general hospital

Taipei, , Taiwan

Site Status

Taipei Tzu Chi hospital

Taipei, , Taiwan

Site Status

CGMH Linkou

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

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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1237-0086

Identifier Type: -

Identifier Source: org_study_id

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