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
1 other identifier
observational
1,617
1 country
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedStudy Start
First participant enrolled
December 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedResults Posted
Study results publicly available
March 11, 2022
CompletedJune 14, 2022
May 1, 2022
10 months
June 28, 2019
October 29, 2021
May 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Annualized Rate of Moderate-to-severe Exacerbation
Up to 1 year after the index date (Baseline).
Annualized Rate of Mild Exacerbation
Up to 1 year after the index date (Baseline).
Annualized Rate of Moderate Exacerbation
Up to 1 year after the index date (Baseline).
Annualized Rate of Severe Exacerbation
Up to 1 year after the index date (Baseline).
Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)
Up to 1 year after the index date (Baseline).
- +6 more secondary outcomes
Study Arms (3)
Subjects with Tiotropium and Olodaterol
Subjects treated with other LABA/LAMA therapy
Subjects treated with LAMA therapy
Interventions
tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium
aclidinium bromide, glycopyrronium, tiotropium, umeclidinium
Eligibility Criteria
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).
You may qualify if:
- Patients who fulfil ALL the following criteria are included.
- 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
- Male or female patients ≥ 40 years of age
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Ditmanson Medical Foundation Chia - Yi Christian Hospital
Chia YI City, 600, Taiwan
CGMH Chia YI
Chia YI City, 613, Taiwan
Eda hospital
Kaohsiung City, 824, Taiwan
CGMH Kaohsiung
Kaohsiung City, 833, Taiwan
Far east memorial hospital
New Taipei City, 220, Taiwan
China medicine memorial hospital
Taichung, 404, Taiwan
VGH Taichung
Taichung, 407, Taiwan
National Taiwan University hospital
Taipei, 100, Taiwan
Makay memorial hospital
Taipei, 104, Taiwan
Cheng Hsin general hospital
Taipei, 112, Taiwan
Taipei Tzu Chi hospital
Taipei, 231, Taiwan
CGMH Linkou
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 8, 2019
Study Start
December 29, 2019
Primary Completion
October 31, 2020
Study Completion
October 31, 2020
Last Updated
June 14, 2022
Results First Posted
March 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
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