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

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Tiotropium (Tio)
Drug: Inhaled corticosteroids (ICS)
Drug: Olodaterol (Olo)
Drug: Long-acting β2-agonists (LABA)

Registration Number: NCT05402020

Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17018

Inclusion Criteria

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.
Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
At least one diagnosis of chronic obstructive pulmonary disease (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

Exclusion Criteria

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;
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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tiotropium + Olodaterol cohort	Olodaterol (Olo)	Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
Tiotropium + Olodaterol cohort	Tiotropium (Tio)	Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort	Long-acting β2-agonists (LABA)	Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.
Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort	Inhaled corticosteroids (ICS)	Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date	From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.	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

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Triple Therapy Initiation	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 (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).
Number of Subjects With Event Triple Therapy Escalation After Index Date	From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.	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.
Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry	From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.	Number of subjects with event the first hospitalization for community-acquired pneumonia after initiation of study drug.
Annualized Rate of Prescriptions of Rescue Medications After the Index Date	From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.	Annualized rate of prescriptions of rescue medications after the index date. Rescue medications were defined as free or combination use of short-acting beta-agonist (SABA) or short-acting muscarinic antagonist (SAMA) or SABA/SAMA. Annualized rates were calculated for each cohort as follows: (total number of events in the cohort during the given time period) / (total person-year at risk from current use of treatment of cohort during the given period).
Annualized Rate of COPD Exacerbations After Index Date	From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.	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.