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

N/ACompletedNCT05402020

Boehringer Ingelheim17,018 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

17,018

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium (Tio)DRUG

Tiotropium (Tio)

Inhaled corticosteroids (ICS)DRUG

Inhaled corticosteroids (ICS)

Olodaterol (Olo)DRUG

Olodaterol (Olo)

Long-acting β2-agonists (LABA)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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);

Locations (1)

National Tawain University Hospital

Taipei, China

Outcomes

Primary Outcomes

Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date

Number of subjects with event first moderate or severe COPD exacerbations after index date. The first dispensing of either Tio/Olo or ICS/LABA combined inhaler was defined as the index date. Definition of moderate or severe COPD exacerbation: 1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field and a prescription for an oral corticosteroid or an antibiotic for respiratory infections 2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD

Time frame: From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Secondary Outcomes

Number of Subjects With Event Triple Therapy Escalation After Index Date

Number of subjects with event triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following: 1. any LAMA/LABA fixed dose combination + any ICS single formulation 2. any LAMA single formulation + any ICS/LABA fixed dose combination 3. any LAMA single formulation + any LABA single formulation + any ICS single formulation The event date was the 30th day after initiation of triple therapy.

Time frame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Incidence Rate of Triple Therapy Initiation

Incidence rate of triple therapy initiation (first event per patient). Triple therapy escalation, defined as any LAMA/ICS/LABA fixed dose combination or any concurrent use for 30 consecutive days of the following: 1. any LAMA/LABA fixed dose combination + any ICS single formulation 2. any LAMA single formulation + any ICS/LABA fixed dose combination 3. any LAMA single formulation + any LABA single formulation + any ICS single formulation Incidence rate calculated as (total number of patients in the cohort experiencing an event of interest for the first time during the given time period) / (total person-time at risk from current use of treatment of cohort during the given period).

Data from ClinicalTrials.gov

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Annualized Rate of COPD Exacerbations After Index Date

Annualized rate of moderate or severe COPD exacerbation after the index date. Annualized rate is calculated as follows: number of moderate or severe COPD exacerbations/total patient year at risk=number of exacerbations per patient year. Definitions of moderate or severe COPD exacerbation were: 1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections, prescriptions within 30 days of each other were considered as continuation of the initial exacerbation. 2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD; hospitalizations or emergency room visits within 30 days of each other were considered as continuation of the initial exacerbation.

Time frame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.