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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402020
• Other study ID #: 1237-0110
• Status: Completed
• Start date: September 30, 2022
• Est. completion date: February 13, 2023

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20775
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium (Tio)
Tiotropium (Tio)
• Inhaled corticosteroids (ICS)
Inhaled corticosteroids (ICS)
• Olodaterol (Olo)
Olodaterol (Olo)
• Long-acting ß2-agonists (LABA)
Long-acting ß2-agonists (LABA)

Device:
• Combined Inhaler
Combined Inhaler

Locations

Country	Name	City	State
China	National Tawain University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first moderate or severe COPD exacerbations after index date		Up to 5 years.
Secondary	Time to triple therapy escalation after index date		Up to 5 years.
Secondary	Incidence rate of triple therapy initiation (first event per patient)		Up to 5 years.
Secondary	Time to the first hospitalization for community-acquired pneumonia after entry		Up to 5 years.
Secondary	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.
Secondary	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.

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