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Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data: Lung Diseases and Conditions – Chronic Obstructive Pulmonary Disease

2022 JUN 13 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Staff editors report on the newly launched clinical trial, NCT05393245, which has the following summary description: “The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).”

As a matter of record, on May 27, 2022, NewsRx staff editors report that the available information provided by Boehringer Ingelheim on this trial include:

Tracking Information

Trial Identifier NCT05393245
First Submitted Date May 23, 2022
First Posted Date May 26, 2022
Results First Submitted Date Not Provided
Results First Posted Date Not Provided
Last Update Submitted Date May 23, 2022
Last Update Posted Date May 26, 2022
Primary Completion Date June 30, 2022
Start Date June 15, 2022
Current Primary Outcome Measures •Incidence rate of adverse events in patients with COPD treated with Tio+Olo [ Time Frame: up to 5 years ]
Current Secondary Outcome Measures •Baseline characteristics of patients who initiated Tio+Olo or other LAMA/LABA [ Time Frame: up to 5 years ]
Other Outcome Measures Not Provided
Change History Complete list of historical revisions of study NCT05393245

Descriptive Information

Brief Title 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
Official Title Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Brief Summary The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).
Detailed Description Not Provided
Study Type Observational
Study Phase Not Provided
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Condition Pulmonary Disease, Chronic Obstructive
Intervention •Drug: Tiotropium+Olodaterol
Tiotropium+Olodaterol
•Device: Spiolto Respimat
Spiolto Respimat Inhaler device
•Drug: Long-acting muscarinic antagonists (LAMAs)
Long-acting muscarinic antagonists (LAMAs)
•Drug: Long-acting b2-agonists (LABAs)
Long-acting b2-agonists (LABAs)
Study Arms •COPD patients treated with tiotropium and olodaterol (Tio+Olo)
Interventions:
⚬Drug: Tiotropium+Olodaterol
⚬Device: Spiolto Respimat
•COPD patients using other Long-acting muscarinic antagonists/Long-acting b2-ago
Interventions:
⚬Drug: Long-acting muscarinic antagonists (LAMAs)
⚬Drug: Long-acting b2-agonists (LABAs)

Recruitment Information

Recruitment Status Not yet recruiting
Estimated Enrollment 4000
Estimated Completion Date June 30, 2022
Primary Completion Date June 30, 2022 (Final data collection date for primary outcome measure)
Eligibility Patients treated with Tio+Olo: Inclusion criteria: At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019. Aged ≥ 40 years on the index date. At least one diagnosis of COPD at any time prior to or on the index date. 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. At least one record in the health insurance system database. Exclusion criteria: Any use of Tio+Olo in free or fixed form within one year prior to the index date. 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 b2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs): Inclusion criteria: 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. Aged ≥ 40 years on the index date. At least one diagnosis of COPD at any time prior to or on the index date- 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. At least one record in the health insurance system database. Exclusion criteria: Any use of LAMA+LABA in free or fixed form for one year prior to the index date. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
Sex/Gender Sexes Eligible for Study: All
Ages 40 years and older
Accepts Healthy Volunteers No
Contacts Primary contact: Boehringer Ingelheim, 1-800-243-0127, [email protected]
Listed Location Countries China
Removed Location Countries

Administrative Information

NCT Number NCT05393245
Other Study ID Numbers 1237-0109
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Studies a U.S. FDA-Regulated Drug Product: Yes
Studies a U.S. FDA-Regulated Device Product: Yes
Plan to Share Data No
Plan to Share Data (IPD) 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
Responsible Party Boehringer Ingelheim
Collaborators Not Provided
Investigators Not Provided
Information Provided By Boehringer Ingelheim
Verification Date May 2022

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