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

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

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Tiotropium+Olodaterol; Device: Spiolto Respimat; Drug: Long-acting muscarinic antagonists (LAMAs); Drug: Long-acting β2-agonists (LABAs)

• Study Type: Observational
• Enrollment (Actual): 19467

Contacts and Locations

Study Locations

• China
  • Taiwan, China, 10617
    • Health Data Research Center, National Taiwan University

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

Chinese patients with chronic obstructive pulmonary disease (COPD) in routine clinical practice in Taiwan.

Description

Patients treated with Tio+Olo:

Inclusion criteria:

1. 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.
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:

1. Any use of Tio+Olo in free or fixed form within 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.

Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):

Inclusion criteria:

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:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD patients treated with tiotropium and olodaterol (Tio+Olo)	Drug: Tiotropium+Olodaterol; Tiotropium+Olodaterol; Device: Spiolto Respimat; Spiolto Respimat Inhaler device
COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)	Drug: Long-acting muscarinic antagonists (LAMAs); Long-acting muscarinic antagonists (LAMAs); Drug: Long-acting β2-agonists (LABAs); Long-acting β2-agonists (LABAs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of adverse events in patients with COPD treated with Tio+Olo	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Baseline characteristics of patients who initiated Tio+Olo or other LAMA/LABA	up to 5 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Olodaterol; Muscarinic Antagonists; Cholinergic Agents
• Other Study ID Numbers: 1237-0109

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: No
• Studies a U.S. FDA-regulated device product: No