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

NCT05393245 | Completed Results

• 1 other identifier: 1237-0109
• Study Type: observational
• Target: 19,467
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events

  Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.

  From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.

• Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events

  Incidence rate of Adverse Events (AEs) in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From index date until the earliest: Outcome of interest, disenrollment, end of the study period, death, discontinuation, use of Inhaled corticosteroids. Incident events. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.

  From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.

Secondary Outcomes (17)

• Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex

  At index date between 2014-2019. Up to 2160 days.

• Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age

  At index date between 2014-2019

• Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry

  At index date between 2014-2019

• Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date

  At index date between 2014-2019

• Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment

  Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.

Study Arms (2)

COPD patients treated with tiotropium and olodaterol (Tio+Olo)

Drug: Tiotropium+Olodaterol; Device: Spiolto Respimat

COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)

Drug: Long-acting muscarinic antagonists (LAMAs); Drug: Long-acting β2-agonists (LABAs)

Interventions

Tiotropium+Olodaterol DRUG

Tiotropium+Olodaterol

COPD patients treated with tiotropium and olodaterol (Tio+Olo)

Spiolto Respimat DEVICE

Spiolto Respimat Inhaler device

COPD patients treated with tiotropium and olodaterol (Tio+Olo)

Long-acting muscarinic antagonists (LAMAs) DRUG

Long-acting muscarinic antagonists (LAMAs)

COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)

Long-acting β2-agonists (LABAs) DRUG

Long-acting β2-agonists (LABAs)

COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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 β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):
• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Health Data Research Center, National Taiwan University

Taiwan, 10617, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

According to Boehringer Ingelheim's internal policy, no document date is required in the title page of the Statistical and Epidemiological Analysis Plan. A direct comparison of the incidence of AEs in similar studies should take into account that the cohorts in the current study were not matched, and, as a consequence, patients treated with Tiotropium/Olodaterol or Other LABA/LAMA presented different baseline characteristics.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

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: May 23, 2022
• First Posted: May 26, 2022
• Study Start: September 30, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)