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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium + Olodaterol; Drug: LAMA; Drug: Other LABA/LAMA

• Registration Number: NCT04011475
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Study Start: 2019-12-29
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Results First Submitted: 2021-10-29
• Results First Submitted QC: 2021-12-22
• Results First Posted: 2022-03-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1617

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Tiotropium and Olodaterol	Tiotropium + Olodaterol	-
Subjects treated with LAMA therapy	LAMA	-
Subjects treated with other LABA/LAMA therapy	Other LABA/LAMA	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Annualized Rate of Severe Exacerbation	Up to 1 year after the index date (Baseline).	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.
Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)	Up to 1 year after the index date (Baseline).	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.
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	At index date (Baseline) and 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.
Annualized Rate of Moderate Exacerbation	Up to 1 year after the index date (Baseline).	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.
Percentage of Patients Using Rescue Medications	Up to 1 year after index date (Baseline).	Percentage of patients using rescue medications within 1 year after index date was reported.
Annualized Rate of Moderate-to-severe Exacerbation	Up to 1 year after the index date (Baseline).	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.
Annualized Rate of Mild Exacerbation	Up to 1 year after the index date (Baseline).	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.
Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy	Up to 1 year after index date (Baseline).	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.
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	At index date (Baseline) and 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.
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	At index date (baseline) and 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.
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	At index date (Baseline) and 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.

Trial Locations

Locations (12)

Ditmanson Medical Foundation Chia - Yi Christian Hospital; 🇨🇳 Chia YI City, Taiwan

CGMH Chia YI; 🇨🇳 Chia YI City, Taiwan

CGMH Kaohsiung; 🇨🇳 Kaohsiung City, Taiwan

Cheng Hsin general hospital; 🇨🇳 Taipei City, Taiwan

CGMH Linkou; 🇨🇳 Taoyuan City, Taiwan

Far east memorial hospital; 🇨🇳 New Taipei City, Taiwan

China medicine memorial hospital; 🇨🇳 Taichung City, Taiwan

Eda hospital; 🇨🇳 Kaohsiung City, Taiwan

Makay memorial hospital; 🇨🇳 Taipei City, Taiwan

VGH Taichung; 🇨🇳 Taichung City, Taiwan

National Taiwan University hospital; 🇨🇳 Taipei City, Taiwan

Taipei Tzu Chi hospital; 🇨🇳 Taipei City, Taiwan