Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
NCT ID: NCT05393245
Last Updated: 2024-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
19467 participants
OBSERVATIONAL
2022-09-30
2022-12-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COPD patients treated with tiotropium and olodaterol (Tio+Olo)
Tiotropium+Olodaterol
Tiotropium+Olodaterol
Spiolto Respimat
Spiolto Respimat Inhaler device
COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)
Long-acting muscarinic antagonists (LAMAs)
Long-acting muscarinic antagonists (LAMAs)
Long-acting β2-agonists (LABAs)
Long-acting β2-agonists (LABAs)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tiotropium+Olodaterol
Tiotropium+Olodaterol
Spiolto Respimat
Spiolto Respimat Inhaler device
Long-acting muscarinic antagonists (LAMAs)
Long-acting muscarinic antagonists (LAMAs)
Long-acting β2-agonists (LABAs)
Long-acting β2-agonists (LABAs)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date.
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
5. At least one record in the health insurance system database.
1. At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date-
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
5. At least one record in the health insurance system database.
Exclusion Criteria
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):
1. Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Data Research Center, National Taiwan University
Taiwan, , China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1237-0109
Identifier Type: -
Identifier Source: org_study_id