Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Tiotropium (Tio); Drug: Olodaterol (Olo); Device: Combined Inhaler; Drug: Inhaled corticosteroids (ICS); Drug: Long-acting β2-agonists (LABA)

• Study Type: Observational
• Enrollment (Actual): 20775

Contacts and Locations

Study Locations

• China
  • Taipei, China, 100225
    • National Tawain University Hospital

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

Patients with chronic obstructive pulmonary disease, included in the NHI database between 2014 and 2019, who received either Tiotropium + Olodaterol or Inhaled Corticosteroids + Long-acting ß2 agonist.

Description

Inclusion Criteria:

1. At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019.

   1. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
   2. For the main analyses, only fixed dose combination (FDC) inhalers will be included.
2. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
3. At least one diagnosis of chronic obstructive pulmonary disease (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, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) 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 (in a sensitivity analysis we will include patients with asthma);

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
Tio/Olo cohort; COPD patients included in the NHI database between 2014 and 2019 and who received Tiotropium/olodaterol (Tio/Olo).	Drug: Tiotropium (Tio); Tiotropium (Tio); Drug: Olodaterol (Olo); Olodaterol (Olo); Device: Combined Inhaler; Combined Inhaler
ICS/LABA cohort; COPD patients included in the NHI database between 2014 and 2019 and who received inhaled corticosteroids/ Long-acting ß2-agonists (ICS/LABA).	Device: Combined Inhaler; Combined Inhaler; Drug: Inhaled corticosteroids (ICS); Inhaled corticosteroids (ICS); Drug: Long-acting β2-agonists (LABA); Long-acting β2-agonists (LABA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to the first moderate or severe COPD exacerbations after index date	Up to 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to triple therapy escalation after index date		Up to 5 years.
Incidence rate of triple therapy initiation (first event per patient)		Up to 5 years.
Time to the first hospitalization for community-acquired pneumonia after entry		Up to 5 years.
Annualized rate of prescriptions of rescue medications after the index date	Annualized rate=number of prescriptions/total patient year at risk. Total patient year at risk=number of prescriptions per patient year.	Up to 5 years.
Annualized rate of moderate or severe COPD exacerbation after the index date	Annualized rate=number of moderate or severe COPD exacerbations/total patient year at risk. Total patient year at risk = number of exacerbations per patient year.	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): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Olodaterol
• Other Study ID Numbers: 1237-0110

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