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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05393245
• Other study ID #: 1237-0109
• Status: Completed
• Start date: September 30, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: January 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19467
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• Lung Diseases
• 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)
• Long-acting ß2-agonists (LABAs)
Long-acting ß2-agonists (LABAs)

Locations

Country	Name	City	State
China	Health Data Research Center, National Taiwan University	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of adverse events in patients with COPD treated with Tio+Olo		up to 5 years
Secondary	Baseline characteristics of patients who initiated Tio+Olo or other LAMA/LABA		up to 5 years

External Links

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