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

Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Tiotropium + Olodaterol; Drug: Other LABA/LAMA; Drug: LAMA

• Study Type: Observational
• Enrollment (Actual): 1617

Contacts and Locations

Study Locations

• Taiwan
  • Chia YI City, Taiwan, 600
    • Ditmanson Medical Foundation Chia - Yi Christian Hospital
  • Chia YI City, Taiwan, 613
    • CGMH Chia YI
  • Kaohsiung City, Taiwan, 824
    • EDA Hospital
  • Kaohsiung City, Taiwan, 833
    • CGMH Kaohsiung
  • New Taipei City, Taiwan, 220
    • Far East Memorial Hospital
  • Taichung City, Taiwan, 404
    • China medicine memorial hospital
  • Taichung City, Taiwan, 407
    • VGH Taichung
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei City, Taiwan, 104
    • Makay memorial hospital
  • Taipei City, Taiwan, 112
    • Cheng Hsin General Hospital
  • Taipei City, Taiwan, 231
    • Taipei Tzu Chi Hospital
  • Taoyuan City, Taiwan, 333
    • CGMH Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The data will be retrospectively abstracted from the medical chart after eligibility assessment. Eligible patients will be categorized into the cohort A (patients treated with Tio + Olo), B (patients treated with other LABA/LAMA therapy), and C (patients treated with LAMA therapy).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Tiotropium and Olodaterol	Drug: Tiotropium + Olodaterol; Spiolto®
Subjects treated with other LABA/LAMA therapy	Drug: Other LABA/LAMA; tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium
Subjects treated with LAMA therapy	Drug: LAMA; aclidinium bromide, glycopyrronium, tiotropium, umeclidinium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Moderate-to-severe Acute Exacerbation	Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported.	Up to 1 year after the index date (Baseline).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Rate of Moderate-to-severe Exacerbation	The annualized rate of moderate-to-severe exacerbation was calculated as: total number of episodes of moderate-to-severe exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.	Up to 1 year after the index date (Baseline).
Annualized Rate of Mild Exacerbation	The annualized rate of mild exacerbation was calculated as: total number of episodes of mild exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.	Up to 1 year after the index date (Baseline).
Annualized Rate of Moderate Exacerbation	The annualized rate of moderate exacerbation was calculated as: total number of episodes of moderate exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.	Up to 1 year after the index date (Baseline).
Annualized Rate of Severe Exacerbation	The annualized rate of severe exacerbation was calculated as: total number of episodes of severe exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.	Up to 1 year after the index date (Baseline).
Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)	Incidence of patients escalating therapy, from single/dual to dual/triple therapy such as receiving Long-Acting Muscarinic Antagonist (LAMA) escalated to dual therapy or receiving LABA+LAMA (Tiotropium+Olodaterol) escalated to triple therapy(LABA+LAMA+inhaled corticosteroids (ICS)), within 1 year after the index date was reported.	Up to 1 year after the index date (Baseline).
Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy	Percentage of patients receiving dual therapy (Tiotropium+Olodaterol or other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) therapy) escalated to triple therapy (LABA+LAMA + inhaled corticosteroids (ICS)) or LAMA escalated to dual therapy (LABA + LAMA) was reported.	Up to 1 year after index date (Baseline).
Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Expiratory Volume in One Second (Post-FEV1) at 12 Months After Index Date	Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by post-bronchodilatorForced Expiratory Volume in one second (Post-FEV1) at 12 months after index date was reported. Spirometry was the most common tool to evaluate the lung function of patients with respiratory disease. Among the results of spirometry, post-bronchodilator Forced Expiratory Volume in one second was used for assisting in the diagnosis, determining disease severity, and following up the prognosis.	At index date (Baseline) and at 12 months after index date.
Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 Months After Index Date	Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 months after index date was reported. Spirometry was the most common tool to evaluate the lung function of patients with respiratory disease. Among the results of spirometry, post-bronchodilator Forced Volume Vital Capacity was used for assisting in the diagnosis, determining disease severity, and following up the prognosis.	At index date (Baseline) and at 12 months after index date.
Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by COPD Assessment Test (CAT) Score at 12 Months After Index Date	Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) score at 12 months after index date was reported. The COPD assessment test (CAT) was a simple, 8-item, health status instrument which provided a simple method for assessing the impact of COPD on the patient's health and the quality of life. Each item was on a 6-point scale: 0 (no impact) to 5 (maximum impact). The CAT score ranging from 0 (better health status) to 40 (worse health status) was calculated by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.	At index date (Baseline) and at 12 months after index date.
Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Modified Medical Research Council Dyspnea Scale (mMRC) at 12 Months After Index Date	Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by modified Medical Research Council dyspnea scale (mMRC) at 12 months after index date is reported. Modified Medical Research Council dyspnea scale (mMRC) is a 5 points scale measuring the severity of dyspnea of patients. The scale ranges from 0 (better outcome) to 4 (worse outcome). The higher the scale value, the more severe the dyspnea is. If mMRC scale of the patient was > 2, it means the patient may suffer from dyspnea.	At index date (baseline) and at 12 months after index date
Percentage of Patients Using Rescue Medications	Percentage of patients using rescue medications within 1 year after index date was reported.	Up to 1 year after index date (Baseline).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Olodaterol
• Other Study ID Numbers: 1237-0086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No